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

Model Number	0196L16
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing related.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.The product had caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used two-way silicone foley catheter.Visual inspection of the sample noted no obvious visual observations.The catheter balloon was attempted to inflate with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water), and solution immediately leaked form a 0.035"pinhole located 0.1515" from the inflation cap.This is out of specification per inspection procedure which states, "the cap and valve must be present and assembled.The tip of the black valve material should be visible on the cap surface [3] without cuts." a potential root cause for this failure could be torn funnel during valve / cap assembly.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 manufacturing related.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.The actual/suspected device was inspected.
Event or Problem Description
It was reported that the customer had an issue with the foley catheter.No additional information was provided.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER COUNCILL 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15190636
• Report Number: 1018233-2022-06174
• Device Sequence Number: 14955821
• Product Code: EZC
• UDI-Device Identifier: 00801741017926
• UDI-Public: (01)00801741017926
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K910846
• 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
• Report Date (Section B): 08/04/2022

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: 12/31/2024
• Device Model Number: 0196L16
• Device Catalogue Number: 0196L16
• Device Lot Number: NGET0865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2020
• 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