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

Model Number	0134L20
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
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.The device was not returned.
Event or Problem Description
It was reported that the urine did not flow after the placement of the foley catheter.Upon removal, it was found that the eyelet was not opened.Per follow-up information received via ibc on 28oct2021, it was stated that the eyelets were not opened before the placement of catheter.
Event or Problem Description
It was reported that urine was not flowing after the placement of foley catheter.Upon removal, it was found that the eyelet was not opened.Per follow-up information received via ibc on 28oct2021, stated that the eyelets were not opened before the placement of catheter.As per the photo sample received, there was a white bump on the drainage funnel.
Additional Manufacturer Narrative
The reported event was confirmed manufacturing related.1 sample was confirmed to exhibit the reported failure.An amber 3 way foley catheter was returned opened without original packaging.A photo sample was also returned.Visual evaluation of the photo and physical sample confirmed the catheter did not have drainage eyes.The catheter does not meet specification, which states to inspect for "correct eye configuration, damaged funnels, drain eye quality, quantity of drainage eyes".Both physical and photo sample confirmed a sharp lump on the catheter drainage funnel.The product was used for treatment purposes.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.The labeling review is not required as the reported event is confirmed manufacturing related.The actual/suspected device was inspected.

• Brand Name: BARDEX®LUBRICATH® FOLEY CATHETER ALCOCK MODEL
• Common Device Name: FOLEY 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12782845
• Report Number: 1018233-2021-07122
• Device Sequence Number: 6025947
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2022

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: 11/30/2024
• Device Model Number: 0134L20
• Device Catalogue Number: 0134L20
• Device Lot Number: MCEN1314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2021
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2020
• 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