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

Catalog Number AA6114

Device Problem Failure to Deflate (4060)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

According to available information, this device had difficult deflation.No other adverse patient effects were reported.

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.

Manufacturer Narrative

After receiving this complaint, we searched for other complaints and we found none regarding the lot number 9055039.This product was made by our subcontractor which was informed about this issue.Checking the quality databases revealed one corrective and preventive action: - monitoring capa-000152: "balloon issues on folysil and silicone prostatic catheters".The trending for inflation/deflation issue on folysil catheters is specifically monitored.On september one used sample was received.After desinfection step.Inflation / deflation test was perfomed and no defect was observed, only an assymetric balloon was observed.No root cause could be defined but the partial asymetry could be explain this deflation issue.

Event Description

According to available information, this device had difficult deflation.No other adverse patient effects were reported.

• Brand Name: FOLYSIL SILICONE CATHETER
• Type of Device: 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: 17795825
• MDR Text Key: 324022876
• Report Number: 9610711-2023-00197
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040127360
• UDI-Public: 3600040127360
• Combination Product (y/n): N
• PMA/PMN Number: K013174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: AA6114
• Device Lot Number: 9055039_AA61141002
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1