MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER

Catalog Number	73024L
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that hair was found inside one of the ea and small particles in the rest of their on-hand inventory (59 ea) for this item.In total, they had 60 ea (5 ca) that were affected with lot # ngkq2761.Per additional information received via email on 25jun2025, it was reported that the lot number for the faulty catheters returned by our patient in our previous conversation was recorded incorrectly.It should be lot: ngjs5061.Per investigator notification received via task on 29sept2025, it was reported that foreign material was found in the additional sample received.Material#73024l and the lot ngkq2761.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.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.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported event.The investigation was not completed due this event being a duplicate of a previously reported event.If additional information is received a supplemental report will be submitted.Corrections: d, e, h.Udi format updated with available product information per gudid.H11: sections 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.
Event or Problem Description
It was reported that hair was found inside one of the ea and small particles in the rest of their on-hand inventory (59 ea) for this item.In total, they had 60 ea (5 ca) that were affected with lot # ngkq2761.Per additional information received via email on 25jun2025, it was reported that the lot number for the faulty catheters returned by our patient in our previous conversation was recorded incorrectly.It should be lot: ngjs5061.Per investigator notification received via task on 29sept2025, it was reported that foreign material was found in the additional sample received.Material#73024l and the lot ngkq2761.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 23199219
• Report Number: 1018233-2025-08761
• Device Sequence Number: 9278932
• Product Code: EZL
• UDI-Device Identifier: 00801741034336
• UDI-Public: (01)00801741034336(11)250410(17)300228(10)NGKQ2761
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K070558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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 Catalogue Number: 73024L
• Device Lot Number: NGKQ2761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2025
• 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