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

Catalog Number	33620
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
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.Udi format updated with available product information per gudid.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 miramichi unit was have issues with the bd silastic catheters, having an increased number of blocked catheters.Customer could flush all they want but nothing comes back out, and water was very hard to remove from the bulb as the catheters collapse on its own pipe.Demi even had to send a patient to er as the patient couldn't deflate the bulb, and another patient almost had the same thing happened to her, but then finally found a way to remove it after playing with it for more than 20 mins.Same thing happened to me the last night i was on call it took me forever to remove the water from the bulb as the pipe would just collapse on itself while trying to remove the water from the bulb.Some patient ends up with very full bladders because of this issue and the only way urine comes out in the bag of from the penis (for the ones that has suprapubic catheters) was if their bladders are super full.This has been happening not just in neguac but everywhere.I had never tested balloon before inserting a catheter ever.There was not a million ways to put a catheter in, and we have been doing so for years, i don't think we all of a sudden lost our ability to put a catheter.

• 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: 23769559
• Report Number: 1018233-2025-10932
• Device Sequence Number: 9750587
• Product Code: EZL
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K951103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2026

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: NGKV1949
• 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: 11/28/2025
• Supplement Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2025
• 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