BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
Report
- Report Number
- 1018233-2020-03108
- Event Type
- Malfunction
- Date Received
- May 11, 2020
- Report Date
- May 26, 2020
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- EZL
- PMA / PMN Number
- K040504
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE REPORTED EVENT COULD NOT BE CONFIRMED. IT WAS UNKNOWN WHETHER THE DEVICE HAD MET SPECIFICATIONS DUE TO NO SAMPLE WAS RETURNED FOR EVALUATION. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. A POTENTIAL FAILURE MODE COULD BE ¿BLOCKED LUMEN¿ WITH A POTENTIAL ROOT CAUSE OF ¿BIOLOGICAL DEPOSITS¿. THE LOT NUMBER IS UNKNOWN THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿3 0086 BARD® FOLEY CATHETER BARD LIMITED FOREST HOUSE CRAWLEY, WEST SUSSEX RH11 9BP UK +44 1293 527 888 C. R. BARD, INC. COVINGTON, GA 30014 USA 1 800 526 4455 WWW.BARDMEDICAL.COM WARNING: DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE THE CATHETER. ENGLISH VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. USE LUER TIP SYRINGE TO INFLATE WITH STATED ML OF STERILE WATER. OR FOR PRE-FILLED PRODUCTS, REMOVE CLIP AND SQUEEZE RESERVOIR TO INFLATE WITH STATED ML OF STERILE WATER. FOR UROLOGICAL USE ONLY. BARD, BARDIA, BARDEX, URIPLAN, EZ-LOK, AND LUBRICATH ARE TRADEMARKS AND/OR REGISTERED TRADEMARKS OF C. R. BARD, INC. MANUFACTURER: TO DEFLATE CATHETER BALLOON: GENTLY INSERT A LUER SLIP TIP SYRINGE IN THE CATHETER VALVE. NEVER USE MORE FORCE THAN IS REQUIRED TO MAKE THE SYRINGE ¿STICK¿ IN THE VALVE. ALLOW THE PRESSURE WITHIN THE BALLOON TO FORCE THE PLUNGER BACK AND FILL THE SYRINGE WITH WATER. IF YOU NOTICE SLOW OR NO DEFLATION, RE-SEAT THE SYRINGE GENTLY. USE ONLY GENTLE ASPIRATION TO ENCOURAGE DEFLATION IF NEEDED. VIGOROUS ASPIRATION MAY COLLAPSE THE INFLATION LUMEN, PREVENTING BALLOON DEFLATION. IF NECESSARY, CONTACT ADEQUATELY TRAINED PROFESSIONAL FOR ASSISTANCE, AS DIRECTED BY HOSPITAL PROTOCOL. SHOULD BALLOON RUPTURE OCCUR, CARE SHOULD BE TAKEN TO ASSURE THAT ALL BALLOON FRAGMENTS HAVE BEEN REMOVED FROM THE PATIENT. VALVE TYPE: USE LUER SLIP TIP SYRINGE. DO NOT USE NEEDLE. RECOMMENDED INFLATION CAPACITIES 3CC BALLOON: USE 5ML STERILE WATER; 5CC BALLOON: USE 10ML STERILE WATER; 15CC BALLOON: USE 20ML STERILE WATER; 20CC BALLOON: USE 25ML STERILE WATER; 30CC BALLOON: USE 35ML STERILE WATER; 40CC BALLOON: USE 45ML STERILE WATER; 75CC BALLOON: USE 80ML STERILE WATER. DO NOT EXCEED RECOMMENDED CAPACITIES. A NEW CONNECTOR WITH A NEEDLE FREE SAMPLE PORT HAS BEEN ADDED TO THIS PRODUCT. INSTRUCTIONS FOR USE FOR THE NEEDLE-FREE SAMPLING 1. KINK THE DRAINAGE TUBING AT A MINIMUM OF 5CM BELOW THE SAMPLING PORT. 2. WIPE THE SURFACE OF THE PORT WITH AN ALCOHOL SWAB. 3. USING AN ASEPTIC TECHNIQUE, POSITION THE SYRINGE (LUER SLIP TIP ONLY) IN THE CENTRE, PERPENDICULAR TO THE SURFACE OF THE PORT, AND THEN PRESS THE TIP OF THE SYRINGE INTO THE SAMPLING PORT. 4. ASPIRATE THE DESIRED VOLUME AND THEN REMOVE THE SYRINGE. 5. WIPE THE SURFACE OF THE PORT WITH AN ALCOHOL SWAB. 6. UNKINK THE TUBING AND SEND THE CORRECTLY LABELLED SPECIMEN TO THE LABORATORY. UNITS THIS IS A SINGLE USE DEVICE. DO NOT RESTERILIZE ANY PORTION OF THIS DEVICE. REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE, AND/OR LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT. DO NOT USE IF PACKAGE IS DAMAGED SINGLE USE DO NOT RESTERILIZE CONTAINS OR PRESENCE OF NATURAL RUBBER LATEX. CAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS. KEEP AWAY FROM SUNLIGHT WARNING: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LAWS AND REGULATIONS. REFER TO DIRECT UNIT LABEL FOR STERILIZATION METHOD UTILIZED STERILIZED BY RADIATION STERILIZED BY ETHYLENE OXIDE OR CONTAINS OR PRESENCE OF PHTHALATES: DI(2-ETHYLHEXYL)PHTHALATE (DEHP) IS A PLASTICIZER USED IN SOME POLYVINYL CHLORIDE MEDICAL DEVICES. DEHP HAS BEEN SHOWN TO PRODUCE A RANGE OF ADVERSE EFFECTS IN EXPERIMENTAL ANIMALS, NOTABLY LIVER TOXICITY AND TESTICULAR ATROPHY. ALTHOUGH THE TOXIC AND CARCINOGENIC EFFECTS OF DEHP HAVE BEEN WELL ESTABLISHED IN EXPERIMENTAL ANIMALS, THE ABILITY OF THIS COMPOUND TO PRODUCE ADVERSE EFFECTS IN HUMANS IS CONTROVERSIAL. THERE IS NO EVIDENCE THAT NEONATES, INFANTS, PREGNANT AND BREAST FEEDING WOMEN EXPOSED TO DEHP EXPERIENCE ANY RELATED ADVERSE EFFECTS. HOWEVER, A LACK OF EVIDENCE OF CAUSATION BETWEEN DEHP-PVC AND ANY DISEASE OR ADVERSE EFFECT DOES NOT MEAN THAT THERE ARE NO RISKS. DEHP USE BY CONSULT INSTRUCTIONS FOR USE LOT NUMBER CATALOG NUMBER FEMALE USE ONLY RELEASED". H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.
IT WAS REPORTED ON A SURVEY RESPONSE THAT THE CATHETER OCCASIONALLY BECOMES BLOCKED BECAUSE OF BACTERIA IN THE BLADDER.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.
IT WAS REPORTED ON A SURVEY RESPONSE THAT THE CATHETER OCCASIONALLY BECOMES BLOCKED BECAUSE OF BACTERIA IN THE BLADDER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 509165 | BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER | LUBRI-SIL ALL SILICONE CATHETER CONNECTED TO LEG BAG | EZL | C.R. BARD, INC. (COVINGTON) -1018233 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |