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

Catalog Number	165818
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this was a foley catheter spontaneous removal event after placement in a home-care patient placed from (b)(6) 2025.When the balloon was checked, it was found to be leaking.As multiple occurrences have been reported in the same patient, there might be possibility of calcification stones, etc.In the urinary tract and monitoring to see if this was caused by the lot.Per follow up information received via rcc on 26sep2025, stated that after leak a broken balloon was confirmed when checked the balloon.
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.All available udi information is being provided.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
The reported event has been confirmed manufacturing related and is being investigated by capas 12866756 & 12474528.Received (3) photo samples.Visual evaluation of the photo samples notes one opened (without original packaging), used silicone foley catheter.Verified material number 165818 and manufacturing lot number ngkp2656.The condition of the affected catheter could not be confirmed from the photos provided.Functional testing was not possible based solely on these photos.Received 1 all silicone foley catheter.Visual inspection noted no obvious observations.During testing, the catheter balloon inflated using in house syringe with 10ml methylene blue solution (3 drops 1percent aq methylene blue per 100ml distilled water).The catheter balloon was found to have a pinhole measuring 0.013 inches.This is out of specification 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, f, 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 this was a foley catheter spontaneous removal event after placement in a home care patient placed from 19sep2025.When the balloon was checked, it was found to be leaking.As multiple occurrences have been reported in the same patient, there might be possibility of calcification stones, etc.In the urinary tract and monitoring to see if this was caused by the lot.Per follow up information received via rcc on 26sep2025, stated that after leak a broken balloon was confirmed when checked the balloon.

• 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: 23169377
• Report Number: 1018233-2025-08677
• Device Sequence Number: 9555370
• Product Code: EZL
• UDI-Device Identifier: 00801741029769
• UDI-Public: (01)00801741029769(11)250303(17)300131(10)NGKP2656
• 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): 03/04/2026

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: NGKP2656
• 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: 09/24/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 03/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2025
• 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