UNKNOWN LATEX FOLEY CATHETER
Report
- Report Number
- 1018233-2025-08006
- Event Type
- Malfunction
- Date Received
- September 12, 2025
- Date of Event
- September 9, 2025
- Report Date
- November 4, 2025
- Manufacturer
- C.R. BARD INC. (COVINGTON) -1018233
- Product Code
- EZC
- UDI-DI
- 00801741068423
- PMA / PMN Number
- K910846
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. UNABLE TO REVIEW THE LABELLING DUE TO UNKNOWN PRODUCT CODE. ALTHOUGH THE PRODUCT FAMILY IS UNKNOWN, THE FOLEY CATHETER IFUS ARE FOUND TO BE ADEQUATE BASED ON PAST REVIEWS. THE DHR REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. THEREFORE, NO ADDITIONAL ACTION REQUIRED AT THIS TIME. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. CORRECTION: B, D, E, F, G, H THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. INITIAL REPORTER NAME: (B)(6). UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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 "WHEN WE TAKE AN INDWELLING URINARY CATHETER (IUC) OUT AND THE PATIENT WAS STILL RETAINING, WE ARE HAVING ISSUES WITH OUR 14FR I/O CAUSING URETHRAL IRRITATION, MICRO-TEARING, SLIGHTLY PINK TINGED URINE FROM TRAUMA, AND PATIENT COMPLAINTS OF FRICTION/PAIN. DUE TO THIS WE ARE HAVING TO REPLACE IUCS INSTEAD OF DOING I/O ON THE PATIENT MORE THAN 1-2 TIMES DUE TO PATIENT AND OR TEAM MEMBER COMPLAINTS. " NO MEDICAL INTERVENTION WAS REPORTED.
IT WAS REPORTED THAT WHEN WE TAKE AN INDWELLING URINARY CATHETER (IUC) OUT AND THE PATIENT WAS STILL RETAINING, THEY WERE HAVING ISSUES WITH THE 14FR I/O CAUSING URETHRAL IRRITATION, MICRO-TEARING, SLIGHTLY PINK TINGED URINE FROM TRAUMA, AND PATIENT COMPLAINTS OF FRICTION/PAIN. DUE TO THIS THEY NEEDED TO REPLACE IUCS INSTEAD OF DOING I/O ON THE PATIENT MORE THAN 1-2 TIMES DUE TO PATIENT AND OR TEAM MEMBER COMPLAINTS. NO MEDICAL INTERVENTION WAS REPORTED.
IT WAS REPORTED THAT "WHEN WE TAKE AN INDWELLING URINARY CATHETER (IUC) OUT AND THE PATIENT WAS STILL RETAINING, WE ARE HAVING ISSUES WITH OUR 14FR I/O CAUSING URETHRAL IRRITATION, MICRO-TEARING, SLIGHTLY PINK TINGED URINE FROM TRAUMA, AND PATIENT COMPLAINTS OF FRICTION/PAIN. DUE TO THIS WE ARE HAVING TO REPLACE IUCS INSTEAD OF DOING I/O ON THE PATIENT MORE THAN 1-2 TIMES DUE TO PATIENT AND OR TEAM MEMBER COMPLAINTS. " NO MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2594699 | UNKNOWN LATEX FOLEY CATHETER | FOLEY CATHETER | EZC | C.R. BARD INC. (COVINGTON) -1018233 | UNK | 00801741068423 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |