BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER
Report
- Report Number
- 1018233-2022-01272
- Event Type
- Malfunction
- Date Received
- March 14, 2022
- Date of Event
- February 15, 2022
- Report Date
- September 20, 2022
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- MJC
- UDI-DI
- 00801741039775
- PMA / PMN Number
- K040658
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REPORTED EVENT WAS CONFIRMED HOWEVER THE CAUSE WAS UNKNOWN. ONE SAMPLE WAS CONFIRMED TO EXHIBIT THE REPORTED FAILURE. THE DEVICE HAD NOT MET SPECIFICATIONS. THE PRODUCT HAD CAUSED THE REPORTED FAILURE. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED (WITHOUT ORIGINAL PACKAGING), USED TEMPERATURE SENSING SILICONE FOLEY CATHETER. VISUAL INSPECTION OF THE SAMPLE NOTED NO OBVIOUS VISIBLE DEFECTS. A CONTINUITY TESTS WAS PERFORMED, AND THE READING 2.746KOHM, 2.115KOHMS, 1.447KOHMS, AND 1.227KOHMS WERE OBTAINED. THIS DOES NOT MEET SPECIFICATION PER INSPECTION PROCEDURE, WHICH STATES, "THE THERMISTOR CONTINUITY SHOULD EXIST AS FOLLOWS: AT ROOM TEMPERATURE THE MULTIMETER READING MUST BE 2.0KO (KILO OHMS) TO 3.0 KO (KILO OHMS)." A POTENTIAL ROOT CAUSE SENSOR WIRE TOO WEAK. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "1. OCCLUDE DRAINAGE TUBING A MINIMUM OF 3 INCHES BELOW THE SAMPLING PORT BY KINKING THE TUBING UNTIL URINE IS VISIBLE UNDER THE ACCESS SITE. 2. SWAB SURFACE OF BARD® EZ-LOK® SAMPLING PORT WITH ANTISEPTIC WIPE. 3. USING ASEPTIC TECHNIQUE, POSITION THE SYRINGE IN THE CENTER OF THE SAMPLING PORT. THE SYRINGE SHOULD BE HELD PERPENDICULAR TO THE SURFACE OF THE SAMPLING PORT (AT APPROXIMATELY 80 - 100 DEGREE ANGLE). PRESS THE SYRINGE FIRMLY AND TWIST GENTLY TO ACCESS THE SAMPLING PORT. 4. SLOWLY ASPIRATE URINE SAMPLE INTO SYRINGE AND REMOVE SYRINGE FROM SAMPLE PORT. 5. UNKINK TUBING AND TRANSFER URINE SPECIMEN INTO SPECIMEN CUP OR FOLLOW HOSPITAL PROTOCOL. DISCARD SYRINGE ACCORDING TO HOSPITAL PROTOCOL. 6. FOLLOW ESTABLISHED HOSPITAL PROTOCOL FOR SPECIMEN LABELING AND TRANSPORT TO LAB. BARD, EZ-LOK AND STATLOCK ARE TRADEMARKS AND/OR REGISTERED TRADEMARKS OF C. R. BARD, INC. ©2018 C. R. BARD, INC. ALL RIGHTS RESERVED. WWW.BARDMEDICAL.COM MANUFACTURER: C. R. BARD, INC. 8195 INDUSTRIAL BLVD. COVINGTON, GA 30014 USA STERILIZED USING ETHYLENE OXIDE STERILE UNLESS PACKAGE IS OPENED OR DAMAGED, EXCEPT FOR ANY INDIVIDUALLY PACKAGED COMPONENTS WITHIN THE TRAY WHICH ARE NOT LABELED AS STERILE. THESE COMPONENTS ARE NOT TERMINALLY STERILIZED. CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. SINGLE USE ONLY. DO NOT RE-STERILIZE. FOR UROLOGICAL USE ONLY. WARNING: ON CATHETER, DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE THE CATHETER AND MAY CAUSE BALLOON TO BURST. WARNING: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICES AND APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. IF PACKAGE IS OPENED OR IF ANY IMPERFECTION OR SURFACE DETERIORATION IS OBSERVED, DO NOT USE. PLEASE CONSULT PRODUCT LABEL AND INSERT FOR ANY INDICATIONS, CONTRAINDICATIONS, HAZARDS, WARNINGS, CAUTIONS AND DIRECTIONS FOR USE." THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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.
UPON FURTHER REVIEW, BD HAS DETERMINED THIS EVENT IS NOT REPORTABLE. 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 THE SENSICA DEVICE HAD A TEMPERATURE DISPLAY ISSUE. THE TEMPERATURE DISPLAY STOPPED WORKING IN THE MIDDLE OF A MONITORING SESSION AND DISPLAYED **** INSTEAD OF THE TEMPERATURE THAT HAD BEEN DISPLAYED PREVIOUSLY. NURSE STATED THAT EVERYTHING WAS STILL HOOKED UP CORRECTLY, BUT THE TEMPERATURE READING WENT BLANK. UNFORTUNATELY, THE PATIENT USING THE DEVICE ON WAS BEING TREATED FOR END-OF-LIFE CARE AND THE DEVICE WAS NOT ACCESSIBLE FOR INVESTIGATION UNTIL THE PREVIOUS DAY. THE NURSE WAS ASKED TO KEEP THE FOLEY CATHETER AND TEMPERATURE CORD SO THAT IT COULD BE SENT IN FOR INVESTIGATION TO DETERMINE IF THE TEMPERATURE CABLE OR FOLEY CATHETER WAS CAUSING THE ISSUE. PER ADDITIONAL EMAIL RECEIVED VIA MAIL ON 18FEB2022, IT WAS STATED THAT THE TEMPERATURE CABLES HAD BEEN ZIP TIED FOR CABLE MANAGEMENT AND SOME TIES WERE VERY TIGHT ON THE DEVICES AT COX BRANSON BUT IN THIS INSTANCE, THE ZIP TIE WAS NOT TOO TIGHT. BIOMED WAS ABLE TO MOVE THE ZIP TIE AROUND AND CONFIRMED IT DID NOT SEEM TO BE CRIMPING THE TEMP CABLE.
IT WAS REPORTED THAT THE SENSICA DEVICE HAD A TEMPERATURE DISPLAY ISSUE. THE TEMPERATURE DISPLAY STOPPED WORKING IN THE MIDDLE OF A MONITORING SESSION AND DISPLAYED INSTEAD OF THE TEMPERATURE THAT HAD BEEN DISPLAYED PREVIOUSLY. NURSE STATED THAT EVERYTHING WAS STILL HOOKED UP CORRECTLY, BUT THE TEMPERATURE READING WENT BLANK. UNFORTUNATELY, THE PATIENT THEY WERE USING THE DEVICE ON WAS BEING TREATED FOR END-OF-LIFE CARE AND THE DEVICE WAS NOT ACCESSIBLE FOR INVESTIGATION UNTIL YESTERDAY. THE NURSE WAS ASKED TO KEEP THE FOLEY CATHETER AND TEMPERATURE CORD SO THAT IT COULD BE SENT IN FOR INVESTIGATION TO DETERMINE IF THE TEMPERATURE CABLE OR FOLEY CATHETER WAS CAUSING THE ISSUE. PER ADDITIONAL EMAIL RECEIVED VIA MAIL ON 18FEB2022, IT WAS STATED THAT THE TEMPERATURE CABLES HAD BEEN ZIP TIED FOR CABLE MANAGEMENT AND SOME TIES WERE VERY TIGHT ON THE DEVICES AT COX BRANSON BUT IN THIS INSTANCE, THE ZIP TIE WAS NOT TOO TIGHT. BIOMED WAS ABLE TO MOVE THE ZIP TIE AROUND AND CONFIRMED IT DID NOT SEEM TO BE CRIMPING THE TEMP CABLE.
IT WAS REPORTED THAT THE SENSICA DEVICE HAD A TEMPERATURE DISPLAY ISSUE. THE TEMPERATURE DISPLAY STOPPED WORKING IN THE MIDDLE OF A MONITORING SESSION AND DISPLAYED INSTEAD OF THE TEMPERATURE THAT HAD BEEN DISPLAYED PREVIOUSLY. NURSE STATED THAT EVERYTHING WAS STILL HOOKED UP CORRECTLY, BUT THE TEMPERATURE READING WENT BLANK. UNFORTUNATELY, THE PATIENT USING THE DEVICE ON WAS BEING TREATED FOR END-OF-LIFE CARE AND THE DEVICE WAS NOT ACCESSIBLE FOR INVESTIGATION UNTIL THE PREVIOUS DAY. THE NURSE WAS ASKED TO KEEP THE FOLEY CATHETER AND TEMPERATURE CORD SO THAT IT COULD BE SENT IN FOR INVESTIGATION TO DETERMINE IF THE TEMPERATURE CABLE OR FOLEY CATHETER WAS CAUSING THE ISSUE. PER ADDITIONAL EMAIL RECEIVED VIA MAIL ON 18FEB2022, IT WAS STATED THAT THE TEMPERATURE CABLES HAD BEEN ZIP TIED FOR CABLE MANAGEMENT AND SOME TIES WERE VERY TIGHT ON THE DEVICES AT COX BRANSON BUT IN THIS INSTANCE, THE ZIP TIE WAS NOT TOO TIGHT. BIOMED WAS ABLE TO MOVE THE ZIP TIE AROUND AND CONFIRMED IT DID NOT SEEM TO BE CRIMPING THE TEMP CABLE.
IT WAS REPORTED THAT THE SENSICA DEVICE HAD A TEMPERATURE DISPLAY ISSUE. THE TEMPERATURE DISPLAY STOPPED WORKING IN THE MIDDLE OF A MONITORING SESSION AND DISPLAYED . INSTEAD OF THE TEMPERATURE THAT HAD BEEN DISPLAYED PREVIOUSLY. NURSE STATED THAT EVERYTHING WAS STILL HOOKED UP CORRECTLY, BUT THE TEMPERATURE READING WENT BLANK. UNFORTUNATELY, THE PATIENT USING THE DEVICE ON WAS BEING TREATED FOR END-OF-LIFE CARE AND THE DEVICE WAS NOT ACCESSIBLE FOR INVESTIGATION UNTIL THE PREVIOUS DAY. THE NURSE WAS ASKED TO KEEP THE FOLEY CATHETER AND TEMPERATURE CORD SO THAT IT COULD BE SENT IN FOR INVESTIGATION TO DETERMINE IF THE TEMPERATURE CABLE OR FOLEY CATHETER WAS CAUSING THE ISSUE. PER ADDITIONAL EMAIL RECEIVED VIA MAIL ON 18FEB2022, IT WAS STATED THAT THE TEMPERATURE CABLES HAD BEEN ZIP TIED FOR CABLE MANAGEMENT AND SOME TIES WERE VERY TIGHT ON THE DEVICES AT COX BRANSON BUT IN THIS INSTANCE, THE ZIP TIE WAS NOT TOO TIGHT. BIOMED WAS ABLE TO MOVE THE ZIP TIE AROUND AND CONFIRMED IT DID NOT SEEM TO BE CRIMPING THE TEMP CABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1324453 | BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER | TEMPERATURE SENSING FOLEY CATHETER | MJC | C.R. BARD, INC. (COVINGTON) -1018233 | SCCS1002 | NGFX5341 | 00801741039775 |
| 1667034 | BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER | TEMPERATURE SENSING FOLEY CATHETER | MJC | C.R. BARD, INC. (COVINGTON) -1018233 | SCCS1002 | NGFX5341 | 00801741039775 |
| 1873300 | BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER | TEMPERATURE SENSING FOLEY CATHETER | MJC | C.R. BARD, INC. (COVINGTON) -1018233 | SCCS1002 | NGFX5341 | 00801741039775 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |