BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP
Report
- Report Number
- 1018233-2025-05587
- Event Type
- Malfunction
- Date Received
- July 7, 2025
- Date of Event
- July 3, 2025
- Report Date
- October 17, 2025
- Manufacturer
- C.R. BARD INC. (COVINGTON) -1018233
- Product Code
- KOD
- UDI-DI
- 00801741029875
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
UPON FURTHER REVIEW, BD HAS DETERMINED THAT THIS MDR IS NOT REPORTABLE. SUBMITTING THE INVESTIGATION DETAILS AS ADDITIONAL INFORMATION. THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED . IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR UROLOGICAL CARE. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE OPERATOR ERROR OR MECHANICAL FAILURE DURING LEACHING PROCESS THAT CAN LEAD TO THE PRODUCT ABOVE WATER LEVEL OF TANK THAT POTENTIALLY CAUSES REACTION IN PATIENT DUE TO EXCESS ACCELERANTS AND PROTEINS. THE REPORTED EVENT IS ADDRESSED IN STEP/ITEM LEACHING. A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE OPERATOR ERROR OR MECHANICAL FAILURE THAT CAN LEAD TO THE PRODUCT ABOVE WATER LEVEL OF TANK THAT POTENTIALLY CAUSES REACTION IN PATIENT DUE TO EXCESS ACCELERANTS AND PROTEINS. BASED ON INFORMATION IN THE PFMEA, THE RISK OF THIS FAILURE IS MEDIUM. CURRENT CONTROLS IN PLACE ARE ADEQUATE TO MITIGATE THIS FAILURE MODE. A REVIEW OF THE DEVICE LABELLING HAS BEEN CONDUCTED FOR INVESTIGATION PURPOSED. THE IFU IS ATTACHED IN THE INVESTIGATION OVERVIEW ELEMENT. THE LABELING AND INSTRUCTIONS FOR USE WERE FOUND TO BE ADEQUATE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THEREFORE, NO ADDITIONAL ACTION REQUIRED AT THIS TIME. CORRECTION: D, F, 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.
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR UROLOGICAL CARE. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE OPERATOR ERROR OR MECHANICAL FAILURE DURING LEACHING PROCESS THAT CAN LEAD TO THE PRODUCT ABOVE WATER LEVEL OF TANK THAT POTENTIALLY CAUSES REACTION IN PATIENT DUE TO EXCESS ACCELERANTS AND PROTEINS. A REVIEW OF THE DEVICE LABELLING HAS BEEN CONDUCTED FOR INVESTIGATION PURPOSED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THEREFORE, NO ADDITIONAL ACTION REQUIRED AT THIS TIME. CORRECTION: E. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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 STATED THAT THE BD REF 010116 INTERMITTENT CATHETER NEW LOT WITH DESIGN COLOR CHANGE: (B)(6) AND OLD LOT NGGR2423-DARK REDDISH SMALL EYELET SLIGHTLY NEW RAW MATERIAL CHANGE HAPPENED ACCORDING TO MED INFO WHICH COULD EXPLAIN THE COLOR CHANGE. CUSTOMER ADVISED THAT THEY WERE EXPERIENCING BLEEDING WHEN USING. NO MEDICAL INTERVENTION WAS REPORTED.
IT WAS REPORTED THAT THE CUSTOMER STATED THAT THE BD REF 010116 INTERMITTENT CATHETER NEW LOT WITH DESIGN COLOR CHANGE: NGJW1905 AND OLD LOT NGGR2423-DARK REDDISH SMALL EYELET SLIGHTLY NEW RAW MATERIAL CHANGE HAPPENED ACCORDING TO MED INFO WHICH COULD EXPLAIN THE COLOR CHANGE. CUSTOMER ADVISED THAT THEY WERE EXPERIENCING BLEEDING WHEN USING. NO MEDICAL INTERVENTION WAS REPORTED.
IT WAS REPORTED THAT THE CUSTOMER STATED THAT THE BD REF 010116 INTERMITTENT CATHETER NEW LOT WITH DESIGN COLOR CHANGE: NGJW1905 AND OLD LOT NGGR2423-DARK REDDISH SMALL EYELET. SLIGHTLY NEW RAW MATERIAL CHANGE HAPPENED ACCORDING TO MED INFO WHICH COULD EXPLAIN THE COLOR CHANGE. CUSTOMER ADVISED THAT THEY WERE EXPERIENCING BLEEDING WHEN USING. NO MEDICAL INTERVENTION WAS REPORTED. PER CUSTOMER VIA PHONE ON 03OCT2025 IT WAS REPORTED THAT THEY HAD ISSUES WITH THE CATHETERS BEING MANUFACTURED IN MALAYSIA. DESCRIBED THEM AS BEING BRIGHT ORANGE IN COLOR AND HAVING A BIGGER EYELET WHICH CAUSED BLEEDING UPON INSERTION BECAUSE IT WAS CUTTING INTO THEIR SKIN. LOT NGJW1905 WAS CONFIRMED AS THE AFFECTED LOT. CUSTOMER STATED THAT THEY RECEIVED THE CATHETERS FROM BYRUM HEALTHCARE. NO MEDICAL INTERVENTION WAS NEEDED. CUSTOMER STATED THAT THEY JUST DISCONTINUED USE OF THAT PARTICULAR LOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 951813 | BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP | INTERMITTENT CATHETER | KOD | C.R. BARD INC. (COVINGTON) -1018233 | NGJW1905 | 00801741029875 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |