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

Catalog Number	AA6C18
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information, the catheter tip came loose prior to catheterization.
Additional Manufacturer Narrative
B3: estimated date.
Event or Problem Description
According to the available information, the catheter tip came loose prior to catheterization.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn't find other complaint regarding the lot number 9177753 with the same defect.We received one opened sample.This medical device was opened in transversal precut and not in longitudinal part and distal tip of the catheter was broken or cut during transverse opening.Transverse opening must be used with great caution to take care not to damage the product.Checking the quality database revealed one change control possibly in connection with the described defect: cc tw (b)(4) "packaging - addition of longitunal precuts" opened on september 2013 and closed on january 2014.Since implantation of change control tw (b)(4), it is strongly recommended to use longitudinal precuts.Transversal precut is not recommended and should be used with great caution.In addition, on march 2025, the quality team performed tensile test on folysil tips to check the conformity of tip hold.The tests were done folysil ch16 received sealed and sterilized from our stock.For tensile test from ch14 to ch24, the specification is = 20n.The results are between 32 and 71n with a mean at 60n.So the results showed that the tip hold is conformed to our specification.Based on the information received and our data, we cannot conclude on a specific root cause in this case.A rmf evaluation was performed based on criq247, risk identfied 11203 & 12202 (hazardous situation: catheter cannot be introduced (or with difficulty)).The evaluation has shown that risks are adequately controlled and reduced as far as possible in the state of art level (except risk 11500).Based on this, we can conclude that residual risks except for risk 11500 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.

• 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: 21600525
• Report Number: 9610711-2025-00053
• Device Sequence Number: 8938894
• Product Code: EZL
• UDI-Device Identifier: 03600040131992
• UDI-Public: 3600040131992
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/16/2025

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: AA6C18
• Device Lot Number: 9177753_AA6C181002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2025
• 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: 03/13/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2023
• 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