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

Catalog Number	AA6318
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: estimated date.
Event or Problem Description
According to the available information, during patient indwelling, the balloon burst and fell out.
Event or Problem Description
According to the available information, during patient indwelling, the balloon burst and fell out.
Additional Manufacturer Narrative
We received one used sample.After desinfection we can observed that balloon was burst without missing part, and intermediate lot number marked on the valve is: 9291248.Traceability of this lot was performed and conclude that this intermediate lot number was used to performed only one lot of product aa63181002 lot number 9472425.The issue of bursting silicone balloon could come from various causes.In this case, we cannot identify any specific root cause because the information provided is insufficient to do so.In parallel, the capa (corrective and preventive action) capa-000152 "balloon issues on folysil and prostatic catheters" was opened and monthly monitored.No corrective action will be implemented as our trend is not increasing and the threshold is not exceeded.

• 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 Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 19822785
• Report Number: 9610711-2024-00191
• Device Sequence Number: 18289982
• Product Code: EZL
• UDI-Device Identifier: 03600040128909
• UDI-Public: 03600040128909
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 12/31/2024

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: AA6318
• Device Lot Number: 9472425_AA63181002
• 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
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• 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