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

Model Number	2557H24
Medical Device Problem Codes	Fracture (1260); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
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.The device was not returned.
Event or Problem Description
It was reported that a hole was found in the foley catheter which leaked irrigation and two catheters were replaced.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing related.One sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was used for treatment purposes.An amber 3-way foley catheter was returned opened without original packaging.A photo sample was also returned.No hole was noted in the photo sample.A hole was noted in the irrigation funnel.The hole was confirmed to be by a weak spot caused by webbing.Device does not meet specification, as it does not meet the webbing - maximum acceptable section which states, " if the webbing has a pinhole, it is not acceptable".A potential root cause for this failure could be "program error".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review is not required as the reported event is confirmed as manufacturing related.Corrections: d, h.H11: section a through f - the information provided by bard 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 bard.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that a hole was found in the foley catheter which leaked irrigation and two catheters were replaced.

• Brand Name: BARDEX® LUBRICATH® HEMATURIA COUDE FOLEY CATHETER
• Common Device Name: COUDE 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: 12054180
• Report Number: 1018233-2021-03756
• Device Sequence Number: 3647632
• Product Code: KOD
• UDI-Device Identifier: 00801741025198
• UDI-Public: (01)00801741025198
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

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: Lay User/Patient
• Device Expiration Date: 03/31/2025
• Device Model Number: 2557H24
• Device Catalogue Number: 2557H24
• Device Lot Number: NGEW3917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2020
• 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