MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URETHRAL CATHETER

Model Number	120616
Medical Device Problem Codes	Nonstandard Device (1420); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that customer received 10 of the intermittent catheter and noted that some of the catheter had black residue on the tips and some did not.
Additional Manufacturer Narrative
The reported event is confirmed, manufacturing related.10 unopened tiemann coude catheters were returned.The coude tip of all catheters were within specifications which states, "accept any curve unless catheter is completely straight.".All coude tips aligned with the indicator notch (with the exception of catheter 3 which was observed to be twisted) and the catheter shafts were noted to be smooth.All but two catheters were noted to have scorching marks from the hand burning process within eyelet.The funnel on catheter 3 did not appear to have been cut straight.When catheter this was removed from the packaging, the coude tip did not appear to align with the indicator notch, however, when taped down they were aligned, indicating the catheter was twisted; as the customer did not report this issue and it is unknown if the catheter became twisted during shipment for evaluation, a new complaint will not be created.A potential root cause for this event could be, "operator error".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review is not required as a review of the label could not have prevented the reported event.The actual/suspected device was inspected.
Event or Problem Description
It was reported that customer received 10 of the intermittent catheter and noted that some of the catheter had black residue on the tips and some did not.Per notification from investigator on 26aug2022, during sample evaluation it was found that one of the intermittent catheter was found to have a poorly cut funnel.

• Brand Name: BARD® URETHRAL CATHETER
• Common Device Name: URETHRAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14270520
• Report Number: 1018233-2022-03191
• Device Sequence Number: 5702978
• Product Code: KOD
• UDI-Device Identifier: 00801741029974
• UDI-Public: (01)00801741029974
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2026
• Device Model Number: 120616
• Device Catalogue Number: 120616
• Device Lot Number: NGFW0685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 05/03/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown