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

Catalog Number	AA6416
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information the balloon burst.
Additional Manufacturer Narrative
B3: estimated date.After receiving this complaint, we searched for other complaints, and we found none regarding the lot number 9404768 after disinfection of the used sample, it was tested and no bursting was observed.Balloon was inflated with 15ml of water and we observed that the balloon was pierced, with a very small hole.All the catheters are 100% tested before packaging and no information was received from hospital regarding the use of a needle; therefore, no root cause can be identified.A risk management file evaluation was performed and concluded that the 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.

• 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: 18465210
• Report Number: 9610711-2024-00010
• Device Sequence Number: 19608019
• Product Code: EZL
• UDI-Device Identifier: 03600040129975
• UDI-Public: 3600040129975
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/01/2024

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: AA6416
• Device Lot Number: 9404768_AA64161002
• 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: 01/08/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2023
• 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