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

Catalog Number	2551H20
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
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: 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 approximately 3 hours after placement, the foley catheter was naturally removed, and when the cuff was checked, foley catheter balloon had burst.Part of the cuff part remains inside the bladder.It was removed using a cystoscope.
Additional Manufacturer Narrative
The complete initial reporter's facility name is (b)(6).The reported event was confirmed cause unknown.Received (7) photo samples.The first and second photo sample shows overview of foley catheter with a rupture balloon.The third, fourth and photo shows the closeup view if the balloon burst with missing pieces.The sixth photo shows the missing piece.The seventh photo shows the inflation valve/cap with product information.Visual evaluation of the returned sample noted one opened (without original packaging), used latex foley catheter.Visual inspection of the sample noted the balloon was ruptured.The labeling is found to be adequate to fulfill s03fa211 revision 26.The device history record review could not be performed without a lot number.Based on the results of the investigation, no additional actions are required at this time.Corrections: d, e, 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.
Event or Problem Description
It was reported that approximately 3 hours after placement, the foley catheter was naturally removed, and when the cuff was checked, foley catheter balloon had burst.Part of the cuff part remains inside the bladder.It was removed using a cystoscope.

• Brand Name: BARDEX® LUBRICATH® HEMATURIA 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: 22132476
• Report Number: 1018233-2025-04130
• Device Sequence Number: 7343075
• Product Code: KOD
• UDI-Device Identifier: 00801741025143
• UDI-Public: (01)00801741025143
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K922431
• 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): 09/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 2551H20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown