BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
Report
- Report Number
- 1018233-2019-03085
- Event Type
- Malfunction
- Date Received
- June 12, 2019
- Report Date
- August 1, 2019
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- EZL
- UDI-DI
- 00801741025228
- PMA / PMN Number
- K040504
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- 003
Narratives
THE DEVICE WAS NOT RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE "OVER INFLATION DURING USE" AND POTENTIAL FAILURE MODE " BURST BALLOON ". 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. (FIG. 2) 3. USING ASEPTIC TECHNIQUE, POSITION THE SYRINGE IN THE CENTER OF THE SAMPLING PORT. PRESS THE SYRINGE FIRMLY AND TWIST GENTLY TO ACCESS THE SAMPLING PORT. (FIG. 3) 4. SLOWLY ASPIRATE URINE SAMPLE INTO SYRINGE AND REMOVE SYRINGE FROM SAMPLE PORT. 5. UNKINK TUBING IF NECESSARY 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. PK7646068 05/2018 WWW.BARDMEDICAL.COM MANUFACTURER: BARD MEDICAL DIVISION C. R. BARD, INC. 8195 INDUSTRIAL BLVD. COVINGTON, GA 30014 USA 1.800.526.4455 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 RESTERILIZE. 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." 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 THAT THE BALLOON BURST SHORTLY AFTER IT WAS INSERTED INTO PATIENT.
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 THAT THE BALLOON BURST SHORTLY AFTER IT WAS INSERTED INTO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 487021 | BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER | FOLEY CATHETERS, LUBRICATH®, 2-WAY, SPECIALTY | EZL | C.R. BARD, INC. (COVINGTON) -1018233 | 1758SI16 | NGCZ1792 | 00801741025228 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |