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

Catalog Number	AA6314
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Event or Problem Description
According to available information, this device had a balloon burst.The nurse inflated 10cc of sterile water for testing.After the testing, the nurse placed the device and inflated 10cc of sterile water again.The device slipped out from the patient.The nurse checked the device and found that the balloon broke.No other adverse patient effects were reported.
Additional Manufacturer Narrative
According to the information received, intermediate lot number was 8676840, we can define that the defect product was with item number aa63141002 lot number 9067761.After receiving this complaint, we searched for other complaints and we found none regarding the lot number 9067761.Checking the quality databases revealed one corrective and preventive action and one non-conformity: - monitoring capa-000152: "balloon issues on folysil and silicone prostatic catheters".The trending for inflation/deflation issue on folysil catheters is specifically monitored.- (b)(4) " issue on valves" opened with our supplier.The defect was accepted by our supplier and some actions have been done.We received one used sample.After desinfection and according to the complaint description, balloon was burst without missing part.
Event or Problem Description
According to available information, this device had a balloon burst.The nurse inflated 10cc of sterile water for testing.After the testing, the nurse placed the device and inflated 10cc of sterile water again.The device slipped out from the patient.The nurse checked the device and found that the balloon broke.No other adverse patient effects were reported.

• 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: 17936842
• Report Number: 9610711-2023-00225
• Device Sequence Number: 6401019
• Product Code: EZL
• UDI-Device Identifier: 03600040128640
• UDI-Public: 3600040128640
• Combination Product (Y/N): N
• 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): 04/19/2024

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
• Device Catalogue Number: AA6314
• Device Lot Number: 9067761_AA63141002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2023
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2023
• 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