UNKNOWN LATEX FOLEY CATHETER
Report
- Report Number
- 1018233-2026-02998
- Event Type
- Malfunction
- Date Received
- May 6, 2026
- Date of Event
- April 29, 2026
- Report Date
- May 15, 2026
- Manufacturer
- C.R. BARD INC. (COVINGTON) -1018233
- Product Code
- EZC
- PMA / PMN Number
- K910846
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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- D, G. 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.
OUR TEAM CONDUCTED A REVIEW OF THE REPORTED EVENT, WITH THE AVAILABLE INFORMATION TO ENSURE THE ONGOING SAFETY AND PERFORMANCE OF THE PRODUCT. AS THIS INVESTIGATION HAS ALREADY BEEN PERFORMED FOR A SIMILAR COMPLAINT, ANOTHER INVESTIGATION IS NOT NECESSARY. AN INVESTIGATION HAS BEEN COMPLETED USING ALL INFORMATION CURRENTLY AVAILABLE. IT REPRESENTS A KNOWN FAILURE MODE THAT HAS BEEN ASSESSED IN THE PRODUCT RISK MANAGEMENT FILE IN ACCORDANCE WITH APPLICABLE REGULATORY STANDARDS AND INTERNAL PROCEDURES. THE ASSOCIATED RISKS CONTINUE TO BE MONITORED AS PART OF ONGOING POST MARKET ACTIVITIES IN COMPLIANCE WITH BOTH REGULATORY REQUIREMENTS AND LOCAL PROCEDURES. CORRECTION: E THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. H11: SECTIONS 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 CUSTOMER REACHED OUT FROM THE MGH (MASSACHUSETTS GENERAL HOSPITAL) OPERATING ROOM REGARDING SEVERAL 16 FR SURESTEP FOLEY TRAYS IN WHICH THE BALLOON WOULD NOT DEFLATE (3 TOTAL). THE NURSING STAFF UNFORTUNATELY DID NOT CAPTURE THE AFFECTED PRODUCTS OR LOT NUMBERS. IT WAS REQUESTED THAT ANY FUTURE ISSUES INCLUDE RETENTION OF THE AFFECTED PRODUCTS FOR EVALUATION.
IT WAS REPORTED THAT THE CUSTOMER REACHED OUT FROM THE MGH (MASSACHUSETTS GENERAL HOSPITAL) OPERATING ROOM REGARDING SEVERAL 16 FR SURESTEP FOLEY TRAYS IN WHICH THE BALLOON WOULD NOT DEFLATE (3 TOTAL). THE NURSING STAFF UNFORTUNATELY DID NOT CAPTURE THE AFFECTED PRODUCTS OR LOT NUMBERS. IT WAS REQUESTED THAT ANY FUTURE ISSUES INCLUDE RETENTION OF THE AFFECTED PRODUCTS FOR EVALUATION.
IT WAS REPORTED THAT THE CUSTOMER REACHED OUT FROM THE OPERATING ROOM REGARDING SEVERAL 16 FR SURESTEP FOLEY TRAYS IN WHICH THE BALLOON WOULD NOT DEFLATE (3 TOTAL). THE NURSING STAFF UNFORTUNATELY DID NOT CAPTURE THE AFFECTED PRODUCTS OR LOT NUMBERS. IT WAS REQUESTED THAT ANY FUTURE ISSUES INCLUDE RETENTION OF THE AFFECTED PRODUCTS FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 509348 | UNKNOWN LATEX FOLEY CATHETER | FOLEY CATHETER | EZC | C.R. BARD INC. (COVINGTON) -1018233 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |