MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 Bard® Silastic® Foley Catheter; Latex Foley Catheter

Catalog Number	33620
Medical Device Problem Codes	Collapse (1099); Inability to Irrigate (1337)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that both of their robotic-assisted laparoscopic prostatectomy patients from (b)(6) 2026 and (b)(6) 2026 had now presented with foley catheter malfunctions.The patient from (b)(6) 2026 came to the emergency department on (b)(6) 2026 reported several hours without urine output through the catheter and overflow incontinence around it.In the emergency department, the catheter could be forward flushed but not aspirated.When they attempted to change the catheter and deflated the balloon, urine began flowing, but aspiration was still not possible.After removed the catheter, they confirmed the balloon was intact, though it was very difficult to deflate and the balloon port collapsed, complicating deflation.With slow, steady traction on the syringe, they was eventually able to completely deflate it and replace the catheter.The second patient, from (b)(6) 2026, presented to the clinic on (b)(6) 2026 with the same complaint their catheter also flushed easily but could not aspirate.Replacement was similarly difficult due to resistance during balloon deflation, though deflation was ultimately achievable.After removal, the catheter flushed well but still did not aspirate until after the balloon was fully deflated.Unfortunately, they performed another prostatectomy on (b)(6) 2026 using a catheter likely from the same batch, so we hope this patient does not experience similar dysfunction.Please work on obtaining a new catheter supply, ideally before our next prostatectomy scheduled for thursday, (b)(6) 2026.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.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: Bard® Silastic® Foley Catheter
• 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: 24512842
• Report Number: 1018233-2026-01495
• Device Sequence Number: 21360975
• Product Code: EZL
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K951103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2026

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: 33620
• Device Lot Number: NGJZ0362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2025
• 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