BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER
Report
- Report Number
- 1018233-2024-07971
- Event Type
- Malfunction
- Date Received
- December 13, 2024
- Date of Event
- November 26, 2024
- Report Date
- March 4, 2025
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- KOD
- UDI-DI
- 00801741039058
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE REPORTED EVENT WAS UNCONFIRMED. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED THREE OPENED (WITH ORIGINAL PACKAGING), INTERMITTENT LATEX CATHETER. VISUAL INSPECTION OF THE THREE SAMPLE NOTED ALL THREE CATHETERS WERE MEASURED AT THE CORRECT SIZE OF 16FR. AS INDICATED ON THE PRODUCT PACKAGING. THIS MET SPECIFICATION PER COMPONENT REQUIREMENT: "DIMENSIONS: 5.75¿ X 5.75¿. NO ROOT CAUSE COULD BE FOUND BECAUSE THE REPORTED EVENT WAS UNCONFIRMED. A DHR IS NOT REQUIRED SINCE THE REPORTED FAILURE WAS UNCONFIRMED. AS THE REPORTED EVENT IS UNCONFIRMED A LABELING REVIEW IS NOT REQUIRED. CORRECTION: D, E, H. 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.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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 PRODUCT WAS MISLABELED. PATIENT ORDERED 16 FRENCH, WHICH WAS INDICATED ON BOX BUT WHEN OPENED SAW THAT THE CATHETER WAS 14 FRENCH. PER CUSTOMER FOLLOW UP ON 03DEC2024, IT WAS REPORTED THAT CUSTOMER ORDERED 180 16FR URETHRAL CATHETERS FROM (B)(6). WHEN THEY RECEIVED THE ORDER, THEY NOTICED THAT THE CATHETERS WERE VISIBLY SMALLER AND STATED THE SIZE INSIDE THE PACKAGING IS 14FR, AND NOT THE 16FR THAT THEY ORDERED. CUSTOMER REACHED OUT TO (B)(6) AND WAS TOLD THAT THE COMPANY WOULD NOT REPLACE THE CATHETERS OR REIMBURSE THEM. CUSTOMER WAS ADVISED TO REACH OUT TO THE BD CLAIMS DEPARTMENT TO PROCEED FURTHER WITH A CLAIM. NO INJURY OR HARM WAS REPORTED. PER SAMPLE FORM RECEIVED ON 06JAN2025, IT WAS REPORTED THAT THE CATHETER 802516 WITH LOT#NGFZ2474 WAS THE CORRECT SIZE AND WORKED WELL. THE CATHETER 802516 WITH LOT#NGJT0580 WAS SMALLER AND MORE FLEXIBLE AND DID NOT WORK AT ALL. IT KINKED UP WHEN INTRODUCED INTO THE URETHRAL AND WOULD NOT ENTER THE BLADDER.
IT WAS REPORTED THAT PRODUCT WAS MISLABELED. PATIENT ORDERED 16 FRENCH, WHICH WAS INDICATED ON BOX BUT WHEN OPENED SAW THAT THE CATHETER WAS 14 FRENCH. PER CUSTOMER FOLLOW UP ON 03DEC2024, IT WAS REPORTED THAT CUSTOMER ORDERED 180 16FR URETHRAL CATHETERS FROM EDGEPARK. WHEN THEY RECEIVED THE ORDER, THEY NOTICED THAT THE CATHETERS WERE VISIBLY SMALLER AND STATED THE SIZE INSIDE THE PACKAGING IS 14FR, AND NOT THE 16FR THAT THEY ORDERED. CUSTOMER REACHED OUT TO EDGEPARK AND WAS TOLD THAT THE COMPANY WOULD NOT REPLACE THE CATHETERS OR REIMBURSE THEM. CUSTOMER WAS ADVISED TO REACH OUT TO THE BD CLAIMS DEPARTMENT TO PROCEED FURTHER WITH A CLAIM. NO INJURY OR HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2413623 | BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER | URETHRAL CATHETER | KOD | C.R. BARD, INC. (COVINGTON) -1018233 | NGJT0580 | 00801741039058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |