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

Catalog Number	AA6114
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	06/01/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
The investigation is not yet complete, a follow up report will be submitted on completion of the investigation.B2: date is unknown.The patient died in (b)(6) 2024.B3: estimated date.
Event or Problem Description
According to the available information, the patient passed away in (b)(6) 2024 due to sepsis.The patient's family concluded that the use of the folysil catheter had a direct correlation with the patient's death.
Additional Manufacturer Narrative
According to the information known, the quality database was checked and revealed the field safety notice associated with the corrective and preventive action z-0844-2025.All the affected products were recalled on the 5 previous years.The investigation resulted in some corrective actions like the change of the packaging foil, new control tools, and retraining of operators.A similar case study was performed based on the recall scope.Defect: packaging issue or infection from (b)(6) 2025: 17 similar cases were found.A medical assessment was also performed which concluded: the risk of infection cannot be eliminated, essentially through a contamination cascade from the outer pouch breach to the external surface of the inner pouch, then to the surgeon¿s glove, then to the patient.Taking into account the multiple risk ratios for each step of the cascade, and based on the sensitivity analysis performed, the final risk is not expected to exceed the usual highest rates reported in literature for each device family.
Additional Manufacturer Narrative
A similar case study was performed based on the scope of the recall.This included complaints reporting the same identified packaging issue or a report of infection for impacted devices: 18 similar cases were found.

• 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
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 21458068
• Report Number: 9610711-2025-00037
• Device Sequence Number: 7591441
• Product Code: EZL
• UDI-Device Identifier: 03600040127360
• UDI-Public: 3600040127360
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: AA6114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 11/04/2025; 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0844-2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male