MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER

Model Number	772415
Medical Device Problem Code	Inadequate Instructions for Healthcare Professional (1319)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2020
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 bard urethral catheterization tray with red rubber catheter was having labeling issues and mixed product.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "incorrect/ missing translation; missing instructions; vendor/printer error".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not performed because labeling could not have prevented the reported failure.The device was not returned.
Event or Problem Description
It was reported that the bard urethral catheterization tray with red rubber catheter was having labeling issues and mixed product.

• Brand Name: BARD URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER
• Common Device Name: RED RUBBER CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10705640
• Report Number: 1018233-2020-20221
• Device Sequence Number: 19589492
• Product Code: KOD
• UDI-Device Identifier: 00801741030413
• UDI-Public: (01)00801741030413
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Model Number: 772415
• Device Catalogue Number: 772415
• Device Lot Number: NGER3319
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 02/18/2021
• 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