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

Catalog Number	AA6316
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Hematuria (2558)
Date of Event	12/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information, prior to insertion, the balloon test was done with 15ml of sterile water without difficulty.The placement of the catheter did not present any problem with a good return of urine.Following inflation of the balloon with 15ml of water the urine became pink then hematuric with blood clots.When removing the catheter the nurse observed the ballon burst.A new catheter was placed without pain successfully.
Event or Problem Description
According to additional available information, the indication for use of the catheter was recurrent urinary tract infections/ urinary leakage in a patient at end of life.A urinary catheter insertion set containing a glycerine- based lubricating gel was used.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we found none regarding the lot number 9396698 with the same defect.We received a documentary investigation from our subcontractor about this complaint: raw material's issue was known and registered.This issue can lead to balloon bursting.Checking the quality databases revealed this type of defect is known and closely monitored a similar case study was performed based on same item number: aa6316 and same defect: balloon burst, over the last four years: 8 similar cases were found.A risk management file evaluation was performed and 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 (Section G): CMF-SARLAT; 9 avenue edmond rostand; sarlat-la-caneda ; FR
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18445224
• Report Number: 9610711-2024-00004
• Device Sequence Number: 20535124
• Product Code: EZL
• UDI-Device Identifier: 03600040128770
• UDI-Public: 3600040128770
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K013174
• 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): 06/28/2024

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: AA6316
• Device Lot Number: 9396698_AA63161002
• 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: 01/04/2024
• Supplement Report FDA Received Date: 06/28/2024
• Date Device Manufactured: 09/29/2023
• 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