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

Catalog Number	AA6114
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
According to available information, this device had difficult deflation.No other adverse patient effects were reported.
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.
Additional 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 or Problem Description
According to available information, this device had difficult deflation.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: 17795825
• Report Number: 9610711-2023-00197
• Device Sequence Number: 2189301
• Product Code: EZL
• UDI-Device Identifier: 03600040127360
• UDI-Public: 3600040127360
• 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): 04/17/2024

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: AA6114
• Device Lot Number: 9055039_AA61141002
• 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: 09/21/2023
• Supplement Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2023
• 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