MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEXLUBRICATH FOLEY CATHETER ALCOCK MODEL

Model Number	0134L20
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2020
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 water leaked from the catheter during pretest.
Event or Problem Description
It was reported that water leaked from the catheter during pretest.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing-related.One sample was confirmed to exhibit the reported failure.An amber 3 way foley catheter was returned open with original packaging.The catheter was attempted to be inflated with 35 ccs of di water using a luer lock syringe.Water began to spray from the catheter eye.Lumen to lumen leakage is the cause of the issue.The product does not meet specification, as it would fail functional leak testing.A potential root cause for this failure 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 was not required as the reported event is confirmed manufacturing related.The actual/suspected device was inspected.

• Brand Name: BARDEXLUBRICATH FOLEY CATHETER ALCOCK MODEL
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11066084
• Report Number: 1018233-2020-21985
• Device Sequence Number: 11079031
• Product Code: KOD
• UDI-Device Identifier: 00801741018763
• UDI-Public: (01)00801741018763
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K922431
• 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): 08/03/2021

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: 02/28/2025
• Device Model Number: 0134L20
• Device Catalogue Number: 0134L20
• Device Lot Number: NGET1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 08/30/2021
• 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