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

Catalog Number	AA6112
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information multiple catheter balloons have leaked and a hole was detected in the balloon.
Additional Manufacturer Narrative
On 13th february, we received one used sample which was transfered to our subcontractor for investigation.On 23rd april, we received the investigation report from our subcontractor: the probable root cause of this issue was a problem with balloon¿s raw material.After receiving this complaint, we searched for other complaint and we didn¿t find other complaint on the lot number 9248064.Checking the quality databases revealed one non-conformity in relation to the described defect and a corrective and preventive action are ongoing: - (b)(4): "pb ballons (bulles + agglutinés)" opened in (b)(6) 2023.- capa-000158 "balloon issues on folysil and silicone prostatic catheters".A similar case study was performed based on same item number aa6112 defect: balloon burst over last four year; (b)(4) similar cases were found.
Event or Problem Description
According to the available information multiple catheter balloons have leaked and a hole was detected in the balloon.

• 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: 18703716
• Report Number: 9610711-2024-00036
• Device Sequence Number: 17980077
• Product Code: EZL
• UDI-Device Identifier: 03600040127230
• UDI-Public: 3600040127230
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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: AA6112
• Device Lot Number: 9248064_AA61121002
• 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: 02/14/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2023
• 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