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

Catalog Number	AA6116
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we didn't find another complaint on the lot number 9634404.B3: estimated date.
Event or Problem Description
According to the available information, the tip comes off.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we found none regarding the lot number 9634404.In october 2024, we received one used and two sealed samples.These two sealed samples were opened and inflated with 15ml of water, no issue was observed after 10 days on the air, no issue about functionality and on the tip was observed.On the used sample received: after decontamination, this sample was observed and we can note that balloon was burst without missing part.Tip of this catheter was complete and no issue observed on this part.Quality database was checked and revealed a corrective and preventive action: -capa-000152."balloon issues on folysil and silicone prostatic catheters" was opened and monthly monitoring.No corrective action will be implemented as our trend is not increasing and the threshold is not exceeded.The evaluation has showed that risks are adequately controlled and reduced as far as possible in the state of art.Based on this, we can conclude that residual risks are adequately controlled and reduced as far as possible, and the residual risks associated with the use of the product are acceptable when weighed against the benefits to the patient/user.It is concluded that the risks identified are still acceptable and considered as safe.
Event or Problem Description
According to the available information, the tip comes off.

• 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: 20456240
• Report Number: 9610711-2024-00289
• Device Sequence Number: 18345726
• Product Code: EZL
• UDI-Device Identifier: 03600040127490
• UDI-Public: 3600040127490
• 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): 02/21/2025

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: AA6116
• Device Lot Number: 9634404_AA61161002
• 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: 10/15/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• 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