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

Catalog Number	0167V18S
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Discomfort (2330); Hematuria (2558); Abdominal Distention (2601)
Date of Event	09/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on september 11, the patient underwent a partial transurethral plasmakinetic resection of the prostate under general anesthesia due to prostatic hyperplasia.Postoperatively, an indwelling urinary catheter was maintained with continuous bladder irrigation to facilitate urine drainage and prevent catheter obstruction caused by blood clots.During the morning handover on september 12 (postoperative day 1), the catheter was found to have dislodged.Upon inspection, the retention balloon was observed to be ruptured; the on-duty physician was immediately notified.Following the dislodgement, the patient was unable to void spontaneously and complained of lower abdominal distension and discomfort; a urinary catheter was subsequently reinserted at the bedside, draining pale red urine.Explanations and reassurance were provided to the patient and their family, and relevant precautions were outlined; the family expressed their understanding.
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.

• Brand Name: Bardex® Foley Catheter Silicone Coated
• Common Device Name: Latex 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: 50916292
• Report Number: 1018233-2026-06150
• Device Sequence Number: 5394078
• Product Code: KOD
• UDI-Device Identifier: 00801741019210
• Combination Product (Y/N): N
• 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): 09/24/2026

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: 0167V18S
• Device Lot Number: 260429Y4
• 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: 09/22/2026
• Initial Report FDA Received Date: 09/28/2026
• 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