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

Model Number	0134L20
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
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.
Event or Problem Description
It was reported that the water leaked from the foley catheter after the placement.Also stated that when the user checked the catheter, the shaft was found to be broken and confirmed that there was no problem at the time of the pretest.It was also mentioned that there was a balloon rupture or tear.
Additional Manufacturer Narrative
The reported event was confirmed to be manufacturing related.One sample was confirmed to exhibit the reported failure.An amber 3-way foley catheter was returned opened without original packaging.The shaft of the catheter was found to have been cut by the bagger machine knife, as evident by the blue bagging material noted on the cut shaft.The sample does not meet specification, as it would not pass functional leak testing.A potential root cause for this failure could be "operator error".Photo samples were returned as well.The photo sample also showed that the catheter had a bagger machine cut.Unable to examine balloon for damage based on the photo sample.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review is not required as the reported event is confirmed to be manufacturing related.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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the water leaked from the foley catheter after the placement.Also stated that when the user checked the catheter, the shaft was found to be broken and confirmed that there was no problem at the time of the pretest.It was also mentioned that there was a balloon rupture or tear.

• 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: 12712667
• Report Number: 1018233-2021-06766
• Device Sequence Number: 13813046
• 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): 03/15/2022

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: 05/31/2024
• Device Model Number: 0134L20
• Device Catalogue Number: 0134L20
• Device Lot Number: NGEY0992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2021
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2021
• 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