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

Catalog Number	1758SI12
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	11/05/2025
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.This report references a us equivalent device.The us udi equivalent for this product number is used.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 the foley catheter was placed after orthopedic surgery.Postoperative observation showed no increase in urine output, so when they removed the tape securing the catheter to check for twisting, the catheter slipped out smoothly.The balloon was deflated.It was leaked from the balloon.
Event or Problem Description
It was reported that the foley catheter was placed after orthopedic surgery.Postoperative observation showed no increase in urine output, so when they removed the tape securing the catheter to check for twisting, the catheter slipped out smoothly.The balloon was deflated.It was leaked from the balloon.
Additional Manufacturer Narrative
The reported event has been confirmed manufacturing related and is being investigated by capas 12866756 & 12474528.Visual evaluation of the photo samples notes one opened (without original packaging), used silicone foley catheter with syringe.Verified material number 2758j12 and manufacturing lot number nghw3765.The third photo provides an enlarged view of the catheter balloon, confirming the presence of a rupture.Received 1 all-silicone foley catheter with sample port connector and syringe.Verified material number 2758j12 and manufacturing lot number nghw3765.Visual inspection noted the balloon had ruptured measured 0.2610in.This is out of specification per inspection procedure (b)(4) 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.Refer to capa 12866756 & 12474528 for further details.Correction: d, f, h.This report references a us equivalent device.The us udi equivalent for this product number is used.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® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
• Common Device Name: SILICONE 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: 23604468
• Report Number: 1018233-2025-10396
• Device Sequence Number: 9204165
• Product Code: MJC
• UDI-Device Identifier: 00801741025204
• UDI-Public: (01)00801741025204(11)231115(17)281112(10)NGHW3765
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K984136
• 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): 03/19/2026

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: 1758SI12
• Device Lot Number: NGHW3765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 03/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• 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