MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL SILICONE CATHETER; INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL

Catalog Number	AA6316
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information, the balloon valve has started to rupture, and the balloon could no longer be emptied.Afterwards it turned out that there was grit/dirt near the balloon valve and also in the catheter tube.Three weeks after the new catheter was placed, there was dirt/flakes in the balloon contents.
Additional Manufacturer Narrative
The investigation is not yet complete, a follow up report will be submitted on completion of the investigation.B3: estimated date.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn't find other complaint regarding the lot number 8700269.Photos were available and we could see particles in the seringe coming from the balloon.Additional information were received by the hospital, the balloon was inflated with nacl (sodium chloride).However, according to our ifu sh2115: "inflating the balloon: "inflate the balloon with sterile water to the volume indicated on the package label".The use of sodium chloride could explain the presence of dirt/flakes in the balloon contents and can make it difficult or impossible to deflate the balloon.Checking quality database revealed no anomaly in connection with the described problem.
Event or Problem Description
According to the available information, the doctor sustained a small puncture wound to the right index finger.

• Brand Name: FOLYSIL SILICONE CATHETER
• Common Device Name: INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): CMF-SARLAT
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 21676992
• Report Number: 9610711-2025-00059
• Device Sequence Number: 7768252
• Product Code: EZL
• UDI-Device Identifier: 03600040128770
• UDI-Public: 3600040128770
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K233411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2026

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: AA6316
• Device Lot Number: 8700269_AA63161002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 06/11/2025; 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2022
• 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
• Patient Sex: Unknown