MAUDE Adverse Event Report: C.R. Bard Inc. (Covington) -1018233 Bardex® Foley Catheter Silicone Coated

Catalog Number	0167V22S
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Hematuria (2558)
Date of Event	09/17/2026
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 following transurethral resection of a bladder tumor, a balloon catheter was left in place to facilitate continuous bladder irrigation.During treatment, it was observed that the continuous bladder irrigation drainage was obstructed, and the irrigation fluid could not drain out smoothly.The medical team immediately conducted a bedside examination and confirmed that the catheter had dislodged and the balloon at its tip had ruptured.The faulty catheter was promptly removed, the patient¿s urethra and bladder were assessed, a new catheter was inserted, and continuous bladder irrigation was resumed.The patient was closely monitored for urine color, bleeding volume, urethral injury, and worsening hematuria.Subsequently, the patient¿s condition remained relatively stable, with no serious complications such as massive bleeding or urethral laceration.However, this incident prolonged the duration of the surgical procedure and increased the duration of anesthesia.Furthermore, fragments from the ruptured balloon posed a risk of remaining in the bladder as foreign bodies, potentially leading to secondary infection.

• Brand Name: Bardex® Foley Catheter Silicone Coated
• 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 ; +1(770)784-6100
• MDR Report Key: 50899375
• Report Number: 1018233-2026-06106
• Device Sequence Number: 13439745
• Product Code: KOD
• UDI-Device Identifier: 00801741019234
• UDI-Public: (01)00801741019234(17)280828(10)MYHX1021
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: CH
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0167V22S
• Device Lot Number: MYHX1021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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