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

Catalog Number	120614
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	11/16/2023
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.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.
Event or Problem Description
It was reported that the issue noticed about a month ago.Customer was experiencing discomfort with trying to use them and wanted to make us aware of the issue.There was a lot they received from the va.Customer stated that there were holes all over the catheter.Customer had one to return back for evaluation.As per follow up via mail on 15nov2023, customer took out a box of catheter lot number nghv0201 to use and found out that it was defective.There was a hole below the tip and down the side, this caused pain and discomfort when inserted in the urethra and their bladder did not empty.No medical intervention was reported.
Event or Problem Description
It was reported that the issue noticed about a month ago.Customer was experiencing discomfort with trying to use them and wanted to make us aware of the issue.There was a lot they received from the va.Customer stated that there were holes all over the catheter.Customer had one to return back for evaluation with lot# nghq0269.Per follow up via mail on 15nov2023, customer took out a box of catheter lot number nghv0201 to use and found out that it was defective.There was a hole below the tip and down the side, this caused pain and discomfort when inserted in the urethra and their bladder did not empty.No medical intervention was reported.Per follow up via mail on 11dec2023, the placement of the variation of holes in the catheters.They have kept three boxes of the catheters and returned rest to the company.The catheters had two different holes nowhere near the tip of the catheter.The one on the left side, as it was being inserted, would cause extreme irritation with lot# nghu0540.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event is inconclusive due to the condition of the sample received.Visual evaluation noted received 3 photo samples.First photo sample shows side of packaging box which indicates product catalog number, lot batch number, and lot expiration date.Second and third photo samples show catheter within enclosed packaging showcasing eyelets present on catheter.However, due to the condition of the sample received the reported event is inconclusive.Root cause could not be identified.Although a root cause could not be definitively identified, a potential root cause for this type of failure could be operator error.However, there was insufficient information to confirm this potential root cause.A dhr review did not show any problems or conditions that would have contributed to the reported event.A labelling review is not required as labelling would not have prevented the reported event.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.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18273992
• Report Number: 1018233-2023-08754
• Device Sequence Number: 6014289
• Product Code: KOD
• UDI-Device Identifier: 00801741029967
• UDI-Public: (01)00801741029967
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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 Catalogue Number: 120614
• Device Lot Number: NGHV0201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2023
• 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