MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD TOUCHLESS PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER KIT

Model Number	4A5108
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
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 catheter removed from bard touchless plus unisex, pre-lubricated ureteral cath kit (8fr) and one other kit from the same lot number was bent at the tip and were unable to be used for patient care.
Event or Problem Description
It was reported that the catheter removed from bard touchless plus unisex, pre-lubricated urethral cath kit (8fr) and one other kit from the same lot number was bent at the tip and were unable to be used for patient care.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to "incorrect assembly operation." the device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not required because labeling could not have prevented the reported issue.H11: section a through f - the information provided by bd represents all of 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 TOUCHLESS PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER KIT
• Common Device Name: VINYL URETHRAL CATHETER KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10863796
• Report Number: 1018233-2020-21027
• Device Sequence Number: 3633973
• Product Code: FCM
• UDI-Device Identifier: 00801741030567
• UDI-Public: (01)00801741030567
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K910653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 4A5108
• Device Catalogue Number: 4A5108
• Device Lot Number: NGDZ0236
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 1 YR