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

Catalog Number	165818
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during placement, the foley catheter was placed on (b)(6) and naturally removed on (b)(6).Leak location was unknown.Per internal bd comments received on 22aug2025, reported that18fr silicone or latex catheter.Since the balloon did not inflate even after being naturally removed, it was possible that the balloon catheter was damaged.
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.
Event or Problem Description
It was reported that during placement, the foley catheter was placed on (b)(6) and naturally removed on 17thaugust.Leak location was unknown.Per internal bd comments received on (b)(6) 2025, reported that18fr silicone or latex catheter.Since the balloon did not inflate even after being naturally removed, it was possible that the balloon catheter was damaged.
Additional Manufacturer Narrative
The reported event has been confirmed and is being investigated by capas 12866756 & 12474528.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone foley catheter with syringe.Visual inspection noted no obvious visible observations.The balloon was inflated with 10ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water), and solution immediately leaked from a 0.013" pinhole located on the catheter balloon.This is out of specification per inspection procedure ip7603444, revision 0, which states, "catheter leaks, valve leaks, balloon perforation, lumen to lumen, prematurely deflated and dislodged balloon are not allowed, and must inflate and deflate with the use of a syringe." risk review, labeling review, and dhr review are not required as the event is being investigated per capas 12866756 & 12474528.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.

• Brand Name: BARDEX® 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: 22904061
• Report Number: 1018233-2025-07127
• Device Sequence Number: 7911093
• Product Code: EZL
• UDI-Device Identifier: 00801741029769
• UDI-Public: (01)00801741029769(11)241219(11)290930(10)NGJX3783
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040504
• 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): 12/16/2025

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: 165818
• Device Lot Number: NGJX3783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• 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