LUBRI-SIL® I.C. COMPLETE CARE® TEMPERATURE-SENSING URINE METER FOLEY TRAY
Report
- Report Number
- 1018233-2024-01711
- Event Type
- Malfunction
- Date Received
- April 1, 2024
- Date of Event
- March 8, 2024
- Report Date
- March 15, 2024
- Manufacturer
- C.R. BARD INC. (COVINGTON) -1018233
- Product Code
- MJC
- PMA / PMN Number
- K070582
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE ¿DEFECT GENERATED AT SUPPLIER'S SITE/BRITTLE MATERIAL/INAPPROPRIATE MATERIAL CHOICE" OR COULD BE CONTRIBUTED BY USER RELATED DURING HANDLING THE PRODUCT". THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATES THE FOLLOWING: "BARDARD®® SILVSILVEERR LLUBRIUBRI--SSILIL® ® FOLEY TRAYFOLEY TRAY SINGLE USE ONLY SINGLE USE ONLY [WARNINGS] [WARNINGS] 1. 1. METHOMETHOD FOR USED FOR USE (1) (1) DO NOT INFLATE THE BALLOON IN THE URETHRA. [THE URETHRA MAY BE INJURED.]DO NOT INFLATE THE BALLOON IN THE URETHRA. [THE URETHRA MAY BE INJURED.] (2) (2) DO NOT PDO NOT PULL THE CATHETER HARD. [ULL THE CATHETER HARD. [TTHE BLADDER/URETHRA MAY HE BLADDER/URETHRA MAY BE BE INJUREINJUREDD..]] 2. 2. APPLICABLE PATIENTAPPLICABLE PATIENTSS · ·PATIENTS WITH DELIRIUM WHO MIGHT PULL OUT CATHETER [WHEN PATIENT TUGS AT PATIENTS WITH DELIRIUM WHO MIGHT PULL OUT CATHETER [WHEN PATIENT TUGS AT CATHETER CATHETER UNCONSCIOUSLYUNCONSCIOUSLY, THE BLADDER AND URETHRA MAY BE DAMAGED., THE BLADDER AND URETHRA MAY BE DAMAGED.]] [CONTRAINDICATIONS] [CONTRAINDICATIONS] 1. METHOD 1. METHOD FOR USE:FOR USE: (1) DO NOT REUSE. DO NOT REUSE. (2) DO NOT RESTERILIZE. DO NOT RESTERILIZE. (3) THIS DEVICE CON THIS DEVICE CON TAINS 10% POVIDONE TAINS 10% POVIDONE--IODIIODINENE. FOR PATIENTS WITH PAST HISTORY OF . FOR PATIENTS WITH PAST HISTORY OF ALLERGIC HYPERSENSITIVITY TO POVIDONEALLERGIC HYPERSENSITIVITY TO POVIDONE--IODINE OR IODINE, CONSIDER USING IODINE OR IODINE, CONSIDER USING ALTERNATIVE DISINFECTANTS.ALTERNATIVE DISINFECTANTS. (4) BE CAREFUL THAT THE CATHETER IS NOT EX BE CAREFUL THAT THE CATHETER IS NOT EX POSED TO OINTMENTS, CONTRAST MEDIUM OR POSED TO OINTMENTS, CONTRAST MEDIUM OR OILOIL--BASED LUBRICANTSBASED LUBRICANTS (INCLUDING VEGETABLE O(INCLUDING VEGETABLE OILILS SUCH AS OLIVE OIL, MINERAL OILS S SUCH AS OLIVE OIL, MINERAL OILS SUCH AS WHITE PETROLATUM AND ANIMAL OILS). [THEY MAY DAMAGE THE DEVICE AND SUCH AS WHITE PETROLATUM AND ANIMAL OILS). [THEY MAY DAMAGE THE DEVICE AND MAY BURST BALLOON.]MAY BURST BALLOON.] (5) DO NOT HOLD THE DEVICE WITH FORCEPS, ETC. A DO NOT HOLD THE DEVICE WITH FORCEPS, ETC. A VOID CONTACT WITH ANY BLADES OR VOID CONTACT WITH ANY BLADES OR SHARPSHARP--EDGED INSTRUMENTS. [CEDGED INSTRUMENTS. [CATHETER DAMAGE MAY CAUSATHETER DAMAGE MAY CAUSE E BALLOON RUPTURE AND BALLOON RUPTURE AND ACCIDENTAL BALLOON REMOVAL OR FAILURE TO DEFLATE OR REMOVE THE BALLOON.]ACCIDENTAL BALLOON REMOVAL OR FAILURE TO DEFLATE OR REMOVE THE BALLOON.] 2. APPLICABLE PATIENTS 2. APPLICABLE PATIENTS PATIENTS WITH KNOWN ALLERGY TO SILVER COATED CATHETERPATIENTS WITH KNOWN ALLERGY TO SILVER COATED CATHETER [ [SHAPE, SHAPE, CONFIGURATION CONFIGURATION AND AND PRINCIPLEPRINCIPLESS]] B BARDARD®® SILVER SILVER LLUBRIUBRI--SSILIL®® FOLEY TRAY CONSISTS OFOLEY TRAY CONSISTS OF F A BALLOON CATHETER, URINEA BALLOON CATHETER, URINE--COLLECTING BAG FOR COLLECTING BAG FOR CLOSED DRAINAGE SYSTEM, SYRINGE PREFILLED WITH STERILE WATER, CLOSED DRAINAGE SYSTEM, SYRINGE PREFILLED WITH STERILE WATER, WATERWATER--SOLUBLE LUBRICANT, SOLUBLE LUBRICANT, ANTISEPTIC SOLUTION, TWEEZERS, WATERPROOANTISEPTIC SOLUTION, TWEEZERS, WATERPROOF SHEEF SHEET, GAUZE PADS, COTTON BALLST, GAUZE PADS, COTTON BALLS, , VINYL GLOVESVINYL GLOVES AND AND STATLOCSTATLOCK FOLEYK FOLEY. . SOME CATHETER SOME CATHETER TTYPES OF THE DEVICE MAY HAVE A TEMPERATURE SENSOR FOR MEASURING YPES OF THE DEVICE MAY HAVE A TEMPERATURE SENSOR FOR MEASURING PATIENT¿S CORE BODY TEMPERATUREPATIENT¿S CORE BODY TEMPERATURE AND AND TTHERE ARE SEVERAL TYPES OF CLOSED DRAINAGE BAGS. HERE ARE SEVERAL TYPES OF CLOSED DRAINAGE BAGS. THE BAGTHE BAG AND STATLOCK FOLAND STATLOCK FOLEYEY INCLUDED IN THE TRAY WILL DEPEND ON THE PRODUCT.INCLUDED IN THE TRAY WILL DEPEND ON THE PRODUCT. THE SUR THE SURFACES OF THE CATHETER AFACES OF THE CATHETER ARERE COATED WITH A MINUTE AMOUNT OF COATED WITH A MINUTE AMOUNT OF METALLIC SILVER AND METALLIC SILVER AND FURTHER COATED WITH POLYURETHANE, HAVING ANTIPROLIFERATIVE EFFECTS ON MICROORGANISMS ON FURTHER COATED WITH POLYURETHANE, HAVING ANTIPROLIFERATIVE EFFECTS ON MICROORGANISMS ON 2 THE CATHETER. THE CATHETER. < <MATERIALMATERIAL>> BALLOON CATHETER: SILICONE; SILVER COATING BALLOON CATHETER: SILICONE; SILVER COATING THIS PRODUCT IS MADE WITH BACTI THIS PRODUCT IS MADE WITH BACTI--GUARDGUARD®®* * SILVER ALLOY COATING. SILVER ALLOY COATING. < <SIZES OF CATHETERSSIZES OF CATHETERS>> AVAILABLE IN SIZES 12 TO 22AVAILABLE IN SIZES 12 TO 22 EVERY 2FREVERY 2FR 1. 1. BALLOBALLOOON CATHETERN CATHETER FOLEY CATHETER FOLEY CATHETER T TEMPERATUREEMPERATURE--SENSINGSENSING CATHECATHETERTER 2. 2. ACCESACCESSSORIESORIES CLOSED DRAINAGE BAG CLOSED DRAINAGE BAG ( (THE ILLUSTRATION SHOWS ONE EXAMPLE OF TYPICAL CONFIGURATIONS.THE ILLUSTRATION SHOWS ONE EXAMPLE OF TYPICAL CONFIGURATIONS.)) SYRINGE PREFILLED WITH STERILE WATER SYRINGE PREFILLED WITH STERILE WATER DRAINAGE TUBE DRAINAGE TUBE BARD EZ BARD EZ--LOK SAMPLING PORTLOK SAMPLING PORT C CLIPLIP SHAFT SHAFT SHAFT SHAFT 3 WATE WATER R SOLUBLE LUBRICANTSOLUBLE LUBRICANT ANTISEPTICS: B ANTISEPTICS: BARDARD®® 10% POVIDONE10% POVIDONE--IODINE SOLUTIONIODINE SOLUTION TWEEZERS TWEEZERS GAUZE PADS GAUZE PADS WAT WATERPROOF SHEETERPROOF SHEET COTTON BALLS COTTON BALLS GLOVES GLOVES STATLOCK FOLEY STATLOCK FOLEY [INTENDED USE & EFFECT [INTENDED USE & EFFECT-- EFFICACY]EFFICACY] THE DEVICE COMBINES A DISPOSABLE CATHETER THAT IS DESIGNED TO BE PLACED IN THE BLADDER THE DEVICE COMBINES A DISPOSABLE CATHETER THAT IS DESIGNED TO BE PLACED IN THE BLADDER FOR FOR THE PURPOSE OF URINARY DRAINAGE AND A URINE DRAINAGE BAGTHE PURPOSE OF URINARY DRAINAGE AND A URINE DRAINAGE BAG.. [DIRECTIONS FOR USE] [DIRECTIONS FOR USE] 1. 1. METHOD OF USEMETHOD OF USE (1) CLEANSE THE AREA AROUND THE EXTERNAL URETHRAL MEATUS WITH THE PACKAGED COTTON BALLS CLEANSE THE AREA AROUND THE EXTERNAL URETHRAL MEATUS WITH THE PACKAGED COTTON BALLS IMMERSED IN THE ANTISEPTICS. IMMERSED IN THE ANTISEPTICS. (2) LUBRICATE THE CATHETER SHAFT WITH THE LUBRICANT JELLY. LUBRICATE THE CATHETER SHAFT WITH THE LUBRICANT JELLY. (3) CAREFULLY INSERT THE CATHETER INTO THE URETHRAL MEATUS. AFTER THE BALLOON ADVANCED IN THE BLADDER, ATTACH THE NEEDLELESS SYRINGE, AND GENTLY INFUSE THE SPECIFIED VOLUME OF STERILE WATER TO INFLATE THE BALLOON. (4) PULL THE CATHETER SLIGHTLY TO SEAT THE BALLOON AT THE LEVEL OF THE BLADDER NECK PULL THE CATHETER SLIGHTLY TO SEAT THE BALLOON AT THE LEVEL OF THE BLADDER NECK . . (5) TO DEFLATE AND REMOVE THE BALLOON, TO DEFLATE AND REMOVE THE BALLOON, ATTACH A NEEDLELESS SYRINGE TO LET STERILE WATER IN THE ATTACH A NEEDLELESS SYRINGE TO LET STERILE WATER IN THE BALLOON COME OUT SPONTANEOUSLY THROUGH BALLOON DEFLATION WITHOUT ASPIRATION. AFTER BALLOON COME OUT SPONTANEOUSLY THROUGH BALLOON DEFLATION WITHOUT ASPIRATION. AFTER BALLOON DEFLATION, WITHDRAW THE CATHETER SLOWLY WHILE CONFIRMING THAT NO ABNORMAL BALLOON DEFLATION, WITHDRAW THE CATHETER SLOWLY WHILE CONFIRMING THAT NO ABNORMAL RESISTANCE IS ENCOUNTERED. RESISTANCE IS ENCOUNTERED. 2. 2. PRPRECAUTIONS FOR USEECAUTIONS FOR USE (1) TO SECURE A STERILE FIELD FOR THE PROCEDURE, SPREAD A CLEAN WRAPPING PAPER. TO SECURE A STERILE FIELD FOR THE PROCEDURE, SPREAD A CLEAN WRAPPING PAPER. (2) PLACE WATERPROOF SHEET BENEATH PATIENT¿S BUTTOCKS. (FIG. 1) PLACE WATERPROOF SHEET BENEATH PATIENT¿S BUTTOCKS. (FIG. 1) (3) PUT ON STERILE GLOVES. OPEN TRAY AND PLACE IT ON THE WRAPPING PAPER. (FIG. 2) PUT ON STERILE GLOVES. OPEN TRAY AND PLACE IT ON THE WRAPPING PAPER. (FIG. 2) FIG FIG.1 .1 FIG.2FIG.2 (4) CLEANSE THE AREA AROUND THE EXTERNAL URETHRAL MEATUS WITH THE COTTON BALLS IMMERSED CLEANSE THE AREA AROUND THE EXTERNAL URETHRAL MEATUS WITH THE COTTON BALLS IMMERSED IN THE ANTISEPTICS. (FIG. 3) IN THE ANTISEPTICS. (FIG. 3) (5) LUBRICATE THE DISTAL END OF THE CATHETER WITH WATER LUBRICATE THE DISTAL END OF THE CATHETER WITH WATER - -SOLUBLE LUBRICANT PACKAGED IN THE SOLUBLE LUBRICANT PACKAGED IN THE TRAY. (FIG. 4)TRAY. (FIG. 4) 4 FIG.3 FIG.3 FIG.4FIG.4 (6) INSERT CATHETER INTO THE URETHRAL MEATUS, AND ADVANCE IT UNTIL THE BALLOON ENTERS THE INSERT CATHETER INTO THE URETHRAL MEATUS, AND ADVANCE IT UNTIL THE BALLOON ENTERS THE BLADDER AND URINE FLOWS OUT THROUGH THE CATHETER. USING A SYRINGE PACKAGED IN THE BLADDER AND URINE FLOWS OUT THROUGH THE CATHETER. USING A SYRINGE PACKAGED IN THE TRAY, INFUSE THE SPECIFIED VOLUME OF TRAY, INFUSE THE SPECIFIED VOLUME OF STERILE WATER INTO THE INFLATION LUMEN TO INFLATE THE STERILE WATER INTO THE INFLATION LUMEN TO INFLATE THE BALLOON. (FIG. 5)BALLOON. (FIG. 5) FIG.5FIG.5 (7) PULL CATHETER TO SEAT THE BALLOON AT THE LEVEL OF THE BLADDER NECK AND SECURE PULL CATHETER TO SEAT THE BALLOON AT THE LEVEL OF THE BLADDER NECK AND SECURE PLACEMENT. PLACEMENT. (8) KEEP THE DRAINAGE BAG BELOW THE BLADDER LEVEL WITHOUT TOUCHING KEEP THE DRAINAGE BAG BELOW THE BLADDER LEVEL WITHOUT TOUCHING THE FLOOR. (FIG. 6) THE FLOOR. (FIG. 6) FIG. 6 FIG. 6 (9) WHEN CATHETER WITH TEMPERATURE WHEN CATHETER WITH TEMPERATURE - -SENSING IS USED, CSENSING IS USED, CONNECT LEAD WIRE TO MONITOR ONNECT LEAD WIRE TO MONITOR WITHWITH RELAY CABLERELAY CABLE.. (10) SECURE DRAINAGE TUBE TO BED SHEET WITH CLIP TO ENSURE THAT THERE IS NEITHER TWIST NOR SECURE DRAINAGE TUBE TO BED SHEET WITH CLIP TO ENSURE THAT THERE IS NEITHER TWIST NOR KINK IN THE TUBE. (FIG. 7)KINK IN THE TUBE. (FIG. 7) FIG.7FIG.7 (11) TO DEFLATE BALLOON AND REMOVE CATHETER, INSERT A LUER TIP (NEEDLELESS) SYRINGE IN THE TO DEFLATE BALLOON AND REMOVE CATHETER, INSERT A LUER TIP (NEEDLELESS) SYRINGE IN THE INFLATION VALVE TO ALLOW THE WATER DRAIN SPONTANEOUSLY. AFTER BALLOON DEFLATION, INFLATION VALVE TO ALLOW THE WATER DRAIN SPONTANEOUSLY. AFTER BALLOON DEFLATION, WITHDRAW THE CATHETER WHILE CONFIRMING THAT NO RESISTANCE IS ENCOUNTEREDWITHDRAW THE CATHETER WHILE CONFIRMING THAT NO RESISTANCE IS ENCOUNTERED.. 5 <DIRECTION FOR USE B <DIRECTION FOR USE BARDARD®® EZEZ--LLOKOK®® SAMPLING PORT>SAMPLING PORT> 1) OCCLUDE DRAINAGE TUBING A MINIMUM OF 10 CM BELOW THE SAMPLING PORT BY KINKING OCCLUDE DRAINAGE TUBING A MINIMUM OF 10 CM BELOW THE SAMPLING PORT BY KINKING THE TUBING UNTIL URINE FILLS THE TUBING UP TO NEAR (SLIGHTLY ABOVE) THE SAMPLING PORT. THE TUBING UNTIL URINE FILLS THE TUBING UP TO NEAR (SLIGHTLY ABOVE) THE SAMPLING PORT. 2) SWAB SURFACE OF SITE WITH ANTISEPTIC WI SWAB SURFACE OF SITE WITH ANTISEPTIC WI PE. PE. 3) USING ASEPTIC TECHNIQUE, POSITION THE NEEDLE LESS SYRINGE (SLIP USING ASEPTIC TECHNIQUE, POSITION THE NEEDLE LESS SYRINGE (SLIP - -TIP TYPE OR LUERTIP TYPE OR LUER--LOCK LOCK TYPE) IN THE CENTER OF THE SAMPLING PORT. THE SYRINGE SHOULD BE HELD PERPENDICULAR TYPE) IN THE CENTER OF THE SAMPLING PORT. THE SYRINGE SHOULD BE HELD PERPENDICULAR TO THE SURFACE OF THE SAMPLING PORT. PRESS THE SYRINGE AND TWIST TO LOCK THE SYRINGTO THE SURFACE OF THE SAMPLING PORT. PRESS THE SYRINGE AND TWIST TO LOCK THE SYRINGE E ONTO THE SAMPLING PORT. (FIG. 8)ONTO THE SAMPLING PORT. (FIG. 8) FIG.8 FIG.8 4) ASPIRATE DESIRED VOLUME OF URINE. ASPIRATE DESIRED VOLUME OF URINE. AFTER SAMPLING, DETACH THE SYRINGE. ENSURE THAT AFTER SAMPLING, DETACH THE SYRINGE. ENSURE THAT THE RUBBER STEM OF THE SAMPLING PORT HAS RETURNED TO ITS ORIGINAL POSITION.THE RUBBER STEM OF THE SAMPLING PORT HAS RETURNED TO ITS ORIGINAL POSITION. 5) UNKINK TUBING. UNKINK TUBING. <HOW TO DISCONNECT CATHETER FROM TUBI <HOW TO DISCONNECT CATHETER FROM TUBING>NG> CATHETER IS PRE CATHETER IS PRE--CONNECTED TO EZCONNECTED TO EZ--LOK, AND THE CONNECTING PART IS COVERED WITH RED SEAL LOK, AND THE CONNECTING PART IS COVERED WITH RED SEAL (TAMPER(TAMPER--EVIDENT SEAL). REMOVE THE SEAL BY GRASPING THE TAB AT THE END OF THE SEAL AND EVIDENT SEAL). REMOVE THE SEAL BY GRASPING THE TAB AT THE END OF THE SEAL AND PULLING ALONG PERFORATIONS, AND THEN DISCONNECT THE CATHETER AND THE TUBING USINPULLING ALONG PERFORATIONS, AND THEN DISCONNECT THE CATHETER AND THE TUBING USING ASEPTIC G ASEPTIC TECHNIQUE. (FIG. 9)TECHNIQUE. (FIG. 9) FIG. 9 FIG. 9 (12) WHEN RESISTANCE IS ENCOUNTERED IN INSERTING CATHETER, STOP THE PROCEDURE AND WHEN RESISTANCE IS ENCOUNTERED IN INSERTING CATHETER, STOP THE PROCEDURE AND REMOVE THE CATHETER. REMOVE THE CATHETER. (13) WHEN DEFLATING BALLOON, DO NOT ASPIRATE WITH A SYRINGE WHEN DEFLATING BALLOON, DO NOT ASPIRATE WITH A SYRINGE BY HANDSBY HANDS.. [THE INFLATION [THE INFLATION LUMEN FOR BALLOON DEFLATION MAY BE OCCLUMEN FOR BALLOON DEFLATION MAY BE OCCLUDED BY NEGATIVE PRESSURE, AND AS A RESULT LUDED BY NEGATIVE PRESSURE, AND AS A RESULT THE THE CATHETERCATHETER CANNOT BE REMOVED.]CANNOT BE REMOVED.].. (14) DO NOT STRETCH CATHETER AS DAMAGE TO OR DISLODGEMENT OF LEAD WIRE AS TEMPERATURE DO NOT STRETCH CATHETER AS DAMAGE TO OR DISLODGEMENT OF LEAD WIRE AS TEMPERATURE PROBE MAY CAUSE IMPROPER TEMPERATURE MEASUREMENT. PROBE MAY CAUSE IMPROPER TEMPERATURE MEASUREMENT. (15) WHEN ENDOELECTRIC SURGERY IS PERFORMED, CARE SH WHEN ENDOELECTRIC SURGERY IS PERFORMED, CARE SH OULD BE TAKEN TO PREVENT BURNS IN OULD BE TAKEN TO PREVENT BURNS IN THE LOCAL TISSUE.THE LOCAL TISSUE. (16) DO NOT WET THE LEAD WIRE AND THE JUNCTION WITH EXTENSION CABLE. DO NOT WET THE LEAD WIRE AND THE JUNCTION WITH EXTENSION CABLE. (17) THIS DEVICE IS COMPATIBLE ONLY WITH MONITORS REQUIRING YSI 400 THIS DEVICE IS COMPATIBLE ONLY WITH MONITORS REQUIRING YSI 400 - -SERIES TYPE SERIES TYPE TEMPERATURE PROBES.TEMPERATURE PROBES. (18) NO SUBSTANCE EXCEPT STERILE WATER SHOULD BE U NO SUBSTANCE EXCEPT STERILE WATER SHOULD BE U SED TO INFLATE THE BALLOON. [IF CONTRAST SED TO INFLATE THE BALLOON. [IF CONTRAST 6 MEDIUM IS USED, BALLOON MAY BURST. IF NORMAL SALINE IS USED, CRYSTALLIZED SALT MAY MEDIUM IS USED, BALLOON MAY BURST. IF NORMAL SALINE IS USED, CRYSTALLIZED SALT MAY OCCLUDE THE INFLATION LUMEN TO PREVENT DEFLATION OF THE BALLOON. IF AIR IS USED, AIR MAY OCCLUDE THE INFLATION LUMEN TO PREVENT DEFLATION OF THE BALLOON. IF AIR IS USED, AIR MAY ESCAPE TO CAUSE INADVERTENT DEFLATION OF THESCAPE TO CAUSE INADVERTENT DEFLATION OF THE BALLOON SO THAT THE CATHETER MAY COME E BALLOON SO THAT THE CATHETER MAY COME OUT PREMATURELY.OUT PREMATURELY. ]] (19) DO NOT WIPE CATHETE DO NOT WIPE CATHETE R SURFACE WITH ORGANIC SOLVENTS SUCH AS ALCOHOL. R SURFACE WITH ORGANIC SOLVENTS SUCH AS ALCOHOL. (20) DO NOT ASPIRATE URINE THROUGH DRAINAGE FUNNEL WALL. DO NOT ASPIRATE URINE THROUGH DRAINAGE FUNNEL WALL. (21) SINCE MOVEMENT OF THE BODY, ETC. MAY TWIST OR BEND CATHETER TO CAUSE OCCLUSIO SINCE MOVEMENT OF THE BODY, ETC. MAY TWIST OR BEND CATHETER TO CAUSE OCCLUSIO N, N, CARE SHOULD BE TAKEN TO FIX THE CATHETER SECURELY.CARE SHOULD BE TAKEN TO FIX THE CATHETER SECURELY. (22) WHEN URINARY FLOW CANNOT BE NOTED, CONFIRM THAT THE CATHETER IS NEITHER OCCLUDED NOR WHEN URINARY FLOW CANNOT BE NOTED, CONFIRM THAT THE CATHETER IS NEITHER OCCLUDED NOR BROKEN. BROKEN. (23) AVOID FORCE ON THE CONNECTING PARTS AS THEY MAY BE ACCIDENTALLY DISCONNECTED DUE AVOID FORCE ON THE CONNECTING PARTS AS THEY MAY BE ACCIDENTALLY DISCONNECTED DUE TO THE WEIGHT OF THE DRAINAG TO THE WEIGHT OF THE DRAINAGE BAG ETC. AND MAY CAUSE URINE SPILL.E BAG ETC. AND MAY CAUSE URINE SPILL. (24) DO NOT PULL OR TWIST THE OUTLET TUBE. ALSO, DO NOT SQUEEZE THE DRAINAGE BAG. [THE JOINT DO NOT PULL OR TWIST THE OUTLET TUBE. ALSO, DO NOT SQUEEZE THE DRAINAGE BAG. [THE JOINT OF THE DRAINAGE BAG AND THE OUTLET TUBE MAY BE DAMAGED AND URINE LEAKAGE MAY OF THE DRAINAGE BAG AND THE OUTLET TUBE MAY BE DAMAGED AND URINE LEAKAGE MAY OCCUR.]OCCUR.] (25) WHEN DISPOSING OF URINE, OBSERVE THE WHEN DISPOSING OF URINE, OBSERVE THE FOLLOWIN FOLLOWING;G; 1) REMOVE THE OUTLET TUBE FROM THE HOUSING OF THE URINE DRAINAGE BAG. REMOVE THE OUTLET TUBE FROM THE HOUSING OF THE URINE DRAINAGE BAG. 2) LIFT THE GREEN LEVER TO OPEN WITH HOLDING THE OUTLET TUBE. BE CAREFUL NOT TO PULL THE LIFT THE GREEN LEVER TO OPEN WITH HOLDING THE OUTLET TUBE. BE CAREFUL NOT TO PULL THE OUTLET TUBE WHEN LIFTING THE GREEN LEVER. OUTLET TUBE WHEN LIFTING THE GREEN LEVER. 3) WHEN DISPOSAL OF URINE WAS COMPLETED, CLOSE THE GREEN LEVE WHEN DISPOSAL OF URINE WAS COMPLETED, CLOSE THE GREEN LEVE R AND PUT THE OUTLET TUBE R AND PUT THE OUTLET TUBE INTO THE HOUSING.INTO THE HOUSING. (26) WHEN USING STATLOCK FOLEY, OBSERVE THE FOLLOWING; WHEN USING STATLOCK FOLEY, OBSERVE THE FOLLOWING; 1) DO NOT USE THE STATLOCK DEVICE WHERE LOSS OF ADHERENCE COULD OCCUR, SUCH AS WITH DO NOT USE THE STATLOCK DEVICE WHERE LOSS OF ADHERENCE COULD OCCUR, SUCH AS WITH A CONFUSED PATIENT, UNATTENDED ACCESS DEVICE, DIAPHORETIC OR NONADHERENT SK A CONFUSED PATIENT, UNATTENDED ACCESS DEVICE, DIAPHORETIC OR NONADHERENT SKIN.IN. 2) MI MI NIMIZE CATHETER MANIPULATION DURING STATLOCK STABILIZATION D NIMIZE CATHETER MANIPULATION DURING STATLOCK STABILIZATION DEVICE APPLICATION AND EVICE APPLICATION AND REMOVAL.REMOVAL. 3) DO NOT USE THE STATLOCK DEVICE FOR PATIENTS SHOWING ALLERGIC REACTION TO TAPE OR DO NOT USE THE STATLOCK DEVICE FOR PATIENTS SHOWING ALLERGIC REACTION TO TAPE OR ADHESIVE. ADHESIVE. 4) CONDUCT SKIN ASSESSMENT PRIOR TO APPLICATION AND REPEAT DAI CONDUCT SKIN ASSESSMENT PRIOR TO APPLICATION AND REPEAT DAI LY PER FACILITY LY PER FACILITY PROTOCOL.PROTOCOL. 5) THE STATLOCK DEVICE SHOULD BE ASSESSED D THE STATLOCK DEVICE SHOULD BE ASSESSED D AILY AND CHANGED WHEN CLINICALLY, AILY AND CHANGED WHEN CLINICALLY, INDICATED, AT LEAST EVERY SEVEN DAYS.INDICATED, AT LEAST EVERY SEVEN DAYS. 6) AFTER PLACING THE STATLOCK DEVICE, ALLOW TO DRY COMPLETELY (10 AFTER PLACING THE STATLOCK DEVICE, ALLOW TO DRY COMPLETELY (10 - -15 SECONDS) DUE TO 15 SECONDS) DUE TO ALCOHOL INCLUDED IN SKIN PROTEALCOHOL INCLUDED IN SKIN PROTECTANT.CTANT. 7) USE ALCOHOL PA USE ALCOHOL PA DS WHEN REMOVAL. DO NOT PULL OR FORCE PAD TO DS WHEN REMOVAL. DO NOT PULL OR FORCE PAD TO REMOVE.REMOVE. [PRECAUTIONS] [PRECAUTIONS] 1. 1. PRECAUTIONS FOR USE (EXERCISE CAUTION WHEN USING THE DEVICE IN THE FOLLOWING PATIENTS)PRECAUTIONS FOR USE (EXERCISE CAUTION WHEN USING THE DEVICE IN THE FOLLOWING PATIENTS) 1) 1) EXERCISE CAUTION WHEN USING THE DEVICE IN PATIENTS WITH HIGH URINARY CAEXERCISE CAUTION WHEN USING THE DEVICE IN PATIENTS WITH HIGH URINARY CALCIUM LEVELLCIUM LEVELS S AS ENCRUSTAAS ENCRUSTATION ON THE BALLOON SURFACE, CATHETER OCCLUSION OR DAMAGE MAY OCCUR.TION ON THE BALLOON SURFACE, CATHETER OCCLUSION OR DAMAGE MAY OCCUR. 2. 2. IMPORTANT PRECAUTIONSIMPORTANT PRECAUTIONS 1) 1) WHEN CATHETER IS INADVERTENTLY REMOVED, INSPECT THE BALLOON AND SHAFT OF CATHETER WHEN CATHETER IS INADVERTENTLY REMOVED, INSPECT THE BALLOON AND SHAFT OF CATHETER FOR RUPTURE, DEFECT, ETC. BEFORE INSERTING A NEW CATFOR RUPTURE, DEFECT, ETC. BEFORE INSERTING A NEW CATHETER.HETER. 2) 2) WWHEN HEN ANY PART ANY PART OFOF THETHE BALLOON AND/OR THE CATHETERBALLOON AND/OR THE CATHETER IS MISSING,IS MISSING, CONSIDCONSIDER REMOVING ER REMOVING THEM USING A CYSTOSCOPE.THEM USING A CYSTOSCOPE. 3) 3) WHEN IT IS DIFFICULT TO REMOVE CATHETER BY DEFLATING THE BALLOON, TAKE APPROPRIATE WHEN IT IS DIFFICULT TO REMOVE CATHETER BY DEFLATING THE BALLOON, TAKE APPROPRIATE MEASURES ACCORDING TO THE SECTION ¿TROUBLESHOOTING¿.MEASURES ACCORDING TO THE SECTION ¿TROUBLESHOOTING¿. <T <TROUBLESHOOTROUBLESHOOTING>ING> WHEN IT WHEN IT IS DIFFICULT TO REMOVE CATHETER BY DEFLATING THE BALLOON (EXPRESSED AS IS DIFFICULT TO REMOVE CATHETER BY DEFLATING THE BALLOON (EXPRESSED AS ¿REMOVAL¿REMOVAL--DIFFICULT CASE¿ HEREINAFTER), TAKE APPROPRIATE MEASURES ACCORDING TO THE FOLLOWING DIFFICULT CASE¿ HEREINAFTER), TAKE APPROPRIATE MEASURES ACCORDING TO THE FOLLOWING 7 PROCEDURES. PROCEDURES. THE FOLLOWING TWO METHODS ARE AVAILABLE FOR REMOVAL THE FOLLOWING TWO METHODS ARE AVAILABLE FOR REMOVAL--DIFFIDIFFICULT CASES.CULT CASES. A. NON A. NON--RUPTURUPTURE METHOD (STERILE WATER IS WITHDRAWN WITHOUT BURSTING THE BALLOON.)RE METHOD (STERILE WATER IS WITHDRAWN WITHOUT BURSTING THE BALLOON.) B. BALLOON B. BALLOON--RUPTURE METHODRUPTURE METHOD WITH BALLOON WITH BALLOON--RUPTURE METHOD, FRAGMENTS OF THE RUPTURED BALLOON MAY REMAIN IN THE RUPTURE METHOD, FRAGMENTS OF THE RUPTURED BALLOON MAY REMAIN IN THE BLADDER. THEREFORE, TRY NONBLADDER. THEREFORE, TRY NON--RUPTURE METHOD FIRST.RUPTURE METHOD FIRST. A. NO A. NONN--RUPTURE MRUPTURE METHODETHOD 1) 1) ATTAATTACH LUER TIP SYRINGE TO THE INFLATION VALVE. INJECT AN ADDITIONAL AMOUNT OF STERILE CH LUER TIP SYRINGE TO THE INFLATION VALVE. INJECT AN ADDITIONAL AMOUNT OF STERILE WATER INTO THE INFLATION LUMEN AND PUMP THE PLUNGER.WATER INTO THE INFLATION LUMEN AND PUMP THE PLUNGER. 2) 2) IF SITUATION WOULDN'T BE IMPROVED WITH 1), SEVER THE INFLATION FUNNEL OF VALVE. (FIG. 10) IF SITUATION WOULDN'T BE IMPROVED WITH 1), SEVER THE INFLATION FUNNEL OF VALVE. (FIG. 10) FIG. 10 FIG. 10 3) 3) IF SITUATION WOULDN¿T BE IMPROVED WITH 2), SEVER THE CATHETER SHAFT WHILE HOLDING IT IF SITUATION WOULDN¿T BE IMPROVED WITH 2), SEVER THE CATHETER SHAFT WHILE HOLDING IT WITH FORCEPS SO THAT THE DISTAL SEGMENT MAY NOT BE DRAWN INTO THE URETHRA. (FIG. 11)WITH FORCEPS SO THAT THE DISTAL SEGMENT MAY NOT BE DRAWN INTO THE URETHRA. (FIG. 11) FIG. 11 FIG. 11 4) 4) IF SITUATION WOULDN'T BE IIF SITUATION WOULDN'T BE IMPROVED WITMPROVED WITH 3), INSERT H 3), INSERT A NEEDLE INTO THE INFLATION LUMEN AND A NEEDLE INTO THE INFLATION LUMEN AND PUMP THE PLUNGER. (FIG.12)PUMP THE PLUNGER. (FIG.12) FIG. 12 FIG. 12 5) 5) IF SITUATION WOULDN'T BE IMPROVED WITH 4), INSERT A FINE STEEL WIRE THROUGH THE INFLATION IF SITUATION WOULDN'T BE IMPROVED WITH 4), INSERT A FINE STEEL WIRE THROUGH THE INFLATION LUMEN OF CATHETER. (FIG.13)LUMEN OF CATHETER. (FIG.13) FIG. 13 FIG. 13 B. BALLOON B. BALLOON--RUPTURE METRUPTURE METHODHOD 1) 1) INJEINJECT 100CT 100--200ML/200ML/CC OF SALINE SOLUTION WARMED TO BODY TEMPERATURE INTO THE BLADDER CC OF SALINE SOLUTION WARMED TO BODY TEMPERATURE INTO THE BLADDER THROUGH THE DRAINAGE LUMEN, AND THEN INJECT A LARGE AMOUNT OF WATER INTO THE BALLOON THROUGH THE DRAINAGE LUMEN, AND THEN INJECT A LARGE AMOUNT OF WATER INTO THE BALLOON THROUGH THE INFLATION LUMEN WITH A NEEDLE TO INDUCE RUPTURE. AFTER RUPTURE OF THETHROUGH THE INFLATION LUMEN WITH A NEEDLE TO INDUCE RUPTURE. AFTER RUPTURE OF THE 8 BALLOON, IRRIGATE THE BLADDER. (FIG. 14) FIG. 14 2) IF SITUATION WOULDN'T BE IMPROVED WITH 1), ATTEMPT FOLLOWING PROCEDURES. A) UNDER THE RADIOSCOPIC OBSERVATION, INFUSE A CONTRAST MEDIUM INTO THE BLADDER, AND BURST THE BALLOON BY SUPRAPUBIC PUNCTURE OF THE BLADDER. (FIG. 15) FIG. 15 B) IN MALE PATIENTS, BURST THE BALLOON BY PUNCTURE WITH A NEEDLE FROM THE PERINEAL (OR SUPRAPUBIC) REGION OR THROUGH THE RECTUM UNDER ULTRASONOGRAPHIC GUIDANCE. (FIG. 16) FIG. 16 C) IN FEMALE PATIENTS, BURST THE BALLOON BY INSERTION OF A NEEDLE ALONG THE URETHRA. (FIG. 17) FIG. 17 <MRI SAFETY> 1) NON-CLINICAL STUDIES HAVE SHOWN THAT TEMPERATURE SENSING CATHETER IS MR CONDITIONAL. MR EXAMINATIONS CAN BE SAFELY PERFORMED ON PATIENTS WEARING THIS PRODUCT UNDER THE FOLLOWING CONDITIONS (SELF CERTIFICATION). - STATIC MAGNETIC FIELD STRENGTH: 1.5T,3.0T - GRADIENT OF STATIC MAGNETIC FIELD: 4,000GAUSS/CM OR LESS -WHOLE-BODY MAXIMUM SAR (SPECIFIC ABSORPTION RATE) (MODE) INDICATED BY THE MR SYSTEM:2-W/KG (NORMAL OPERATING MODE) THE MAXIMUM TEMPERATURE RISE THAT CAN OCCUR IN THIS PRODUCT DURING A SCAN TIME OF 15 MINUTES OR LESS PER PULSE SEQUENCE UNDER THE ABOVE CONDITIONS IS 1.7 °C OR LESS. THE ARTIFACT THAT CAN OCCUR WHEN THE PRODUCT IS IMAGED USING THE GRADIENT MAGNETIC MINERAL OIL 9 FIELD ECHO METHOD IN A 3.0T MR SYSTEM IS 10MM FROM THE ACTUAL IMAGE OF THE FIELD ECHO METHOD IN A 3.0T MR SYSTEM IS 10MM FROM THE ACTUAL IMAGE OF THE PPRODUCT.RODUCT. DO NOT PERFORM SCAN DO NOT PERFORM SCAN LONGER THAN 60 MINUTES UNDER THE ABOVE CONDITIONS.LONGER THAN 60 MINUTES UNDER THE ABOVE CONDITIONS. 2) 2) THE PTHE POSITION OF THE WIRE OF THE FOLEY CATHETER WITH TEMPERATURE SENSOR HAS AN OSITION OF THE WIRE OF THE FOLEY CATHETER WITH TEMPERATURE SENSOR HAS AN EFFECT ON THE AMOUNT OF HEATING THAT MAY DEVELOP DURING AN MRI PROCEDURE. EFFECT ON THE AMOUNT OF HEATING THAT MAY DEVELOP DURING AN MRI PROCEDURE. ACCORDINGLY, THE FOLEY CATHETACCORDINGLY, THE FOLEY CATHETER WITH TEMPERATURE SENSOR MUST BE POSITIONED IN A ER WITH TEMPERATURE SENSOR MUST BE POSITIONED IN A STRAISTRAIGHT CONFIGUGHT CONFIGURATION DOWN TRATION DOWN THE CENTER OF THE PATIENT TABLE (I.E., DOWN THE CENTER OF HE CENTER OF THE PATIENT TABLE (I.E., DOWN THE CENTER OF THE MR SYSTEM WITHOUT ANY LOOP) TO PREVENT POSSIBLE EXCESSIVE HEATING ASSOCIATED THE MR SYSTEM WITHOUT ANY LOOP) TO PREVENT POSSIBLE EXCESSIVE HEATING ASSOCIATED WITH AN MRI PROCEDURE.WITH AN MRI PROCEDURE. 3) 3) REMOVE ALL ELECTRICALLY CONDUCTIVE MATERIAL (I.E. THE REMOVABREMOVE ALL ELECTRICALLY CONDUCTIVE MATERIAL (I.E. THE REMOVABLE EXTENSION CLE EXTENSION CABLEABLE, ETC.) , ETC.) FROM THE BORE OF THE MR SYSTEM THAT IS NOT REQUIRED FOFROM THE BORE OF THE MR SYSTEM THAT IS NOT REQUIRED FOR THE PROCEDURE PRIOR TO THE R THE PROCEDURE PRIOR TO THE MR EXAMINATION.MR EXAMINATION. 4) 4) KEEP ELECTRICALLY CONDUCTIVE MATERIAL THAT MUST REMAIN IN THE BORE OF THE MR SYSTEM KEEP ELECTRICALLY CONDUCTIVE MATERIAL THAT MUST REMAIN IN THE BORE OF THE MR SYSTEM FROM DIRECTLY CONTACTING THE PATFROM DIRECTLY CONTACTING THE PATIENT BY PLACING INSULATING MATERIAL SUCH AS FOAM IENT BY PLACING INSULATING MATERIAL SUCH AS FOAM RUBBER PADDING BETWEEN THE CONDUCTIVE MATERIAL AND THE PATIENT.RUBBER PADDING BETWEEN THE CONDUCTIVE MATERIAL AND THE PATIENT. 3 3. MALFUNCTION. MALFUNCTION AND ADVERSEAND ADVERSE EVENTSEVENTS 1) 1) MALFUNCTIONMALFUNCTION - - CATHETER KINKING, DAMAGE, RUPTURECATHETER KINKING, DAMAGE, RUPTURE - - DIFFICULTY OR FAILURE TO REMOVE THE DEVICEDIFFICULTY OR FAILURE TO REMOVE THE DEVICE - - OCCLUSION OF CATHETER INNER LUMENSOCCLUSION OF CATHETER INNER LUMENS - - ENCRUSTATIONENCRUSTATION - - ACCIDENTAL REMOVAL OF THE DEVICE DUE TO LEAKAGE OF STERILE WATACCIDENTAL REMOVAL OF THE DEVICE DUE TO LEAKAGE OF STERILE WATER OR BALLOER OR BALLOON RUPTURE ON RUPTURE - - DEVICE DAMADEVICE DAMAGE DUE TO INAPPROPRIATE USEGE DUE TO INAPPROPRIATE USE - - FAILURE TO MEASURE TEMPERATUREFAILURE TO MEASURE TEMPERATURE - - IMPROPER TEMPERATURE INDICATIONIMPROPER TEMPERATURE INDICATION 2) 2) ADVERSE EVENTSADVERSE EVENTS - - URINARYURINARY--TRACT INFECTIONTRACT INFECTION - - HEMORRHAGE, HEMATURIAHEMORRHAGE, HEMATURIA - - ALLERGY REACTION TO THE DEVICEALLERGY REACTION TO THE DEVICE - - CALCULUS FORMATION CALCULUS FORMATION - - EDEMAEDEMA - - PAPAININ - - DISCOMFODISCOMFORTRT - - INJURY INJURY OF BLADDER OR URETHRALOF BLADDER OR URETHRAL - - URETHRITIS, URINARY INCONTINENCEURETHRITIS, URINARY INCONTINENCE - - RETAINED BALLOON FRAGMENTSRETAINED BALLOON FRAGMENTS [STORAGE METHOD AND EXPIRATION DATE][STORAGE METHOD AND EXPIRATION DATE] 1. 1. STORAGESTORAGE STORE IN A DRY, COOL PLACE AWAY FROM HEAT, MOISTURE, AND DIRECT SUNLIGHT. STORE IN A DRY, COOL PLACE AWAY FROM HEAT, MOISTURE, AND DIRECT SUNLIGHT. 2. 2. EXPEXPIRATION DATEIRATION DATE IN INDICATED ONDICATED ON THE DIRECT PACKAGE AND THE OUTER BOX.THE DIRECT PACKAGE AND THE OUTER BOX. [NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER AND MANUFACTURER] [NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER AND MANUFACTURER] LICENSED MARKETING APPROVAL HOLDER: LICENSED MARKETING APPROVAL HOLDER: MEDICON INC.MEDICON INC. FOREIGN MANUFACTURER: FOREIGN MANUFACTURER: C.R. BARD, INC.C.R. BARD, INC. COUNTRY OF MANUFACTURER COUNTRY OF MANUFACTURER: : USAUSA CONTACT: CONTACT: 01200120--036036--541541 ((CUSTOMER SERVICE)CUSTOMER SERVICE) 10 * *BACTIBACTI--GUARDGUARD SILVER ALLOY COATING IS LICENSED FROM BACTIGUARD AB.SILVER ALLOY COATING IS LICENSED FROM BACTIGUARD AB. BACTI BACTI--GUARD IS A REGISTERED TRADEMARK OF BACTIGUARD AB.GUARD IS A REGISTERED TRADEMARK OF BACTIGUARD AB." H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
IT WAS REPORTED THAT DURING PRETEST, THE SYRINGE CONTAINING STERILE WATER WAS DAMAGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1590234 | LUBRI-SIL® I.C. COMPLETE CARE® TEMPERATURE-SENSING URINE METER FOLEY TRAY | COMPONENT (SYRINGE) | MJC | C.R. BARD INC. (COVINGTON) -1018233 | MYHU2763 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |