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

Model Number	120616
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	Pain (1994)
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.
Event or Problem Description
It was reported that the guide notch on the funnel end of the coude catheter was 90 degrees from the actual curve of the catheter.The patient was able to fully insert the catheter for use; however notes that it was painful during insertion and removal of the catheter.No medical intervention was reported.
Event or Problem Description
It was reported that the guide notch on the funnel end of the coude catheter was 90 degrees from the actual curve of the catheter.The patient was able to fully insert the catheter for use; however notes that it was painful during insertion and removal of the catheter.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was confirmed.A latex intermittent catheter was returned.The catheter was taped to check for tip and curve alignment.The coude indicator was found to be misaligned with the coude tip.The catheter was taped further down to confirm that the misalignment was not due to bend.The curve still appeared to be misaligned.The root cause is "machine error".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use".This instruction would help prevent the use of a defective catheter.".

• Brand Name: BARD® URETHRAL CATHETER
• Common Device Name: TWO EYE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8846600
• Report Number: 1018233-2019-04375
• Device Sequence Number: 2088765
• Product Code: KOD
• UDI-Device Identifier: 00801741029974
• UDI-Public: (01)00801741029974
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2019

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: 08/31/2023
• Device Model Number: 120616
• Device Catalogue Number: 120616
• Device Lot Number: NGDP2913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1