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

Catalog Number	AA6108
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: estimated date.
Event or Problem Description
According to the available information, a child had developed a uti that required medical intervention.
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.
Event or Problem Description
According to the available information, a child had developed a uti that required medical intervention.
Event or Problem Description
According to the available information, a child had developed a uti that required medical intervention.
Additional Manufacturer Narrative
After receiving this complaint, we were unable to investigate further complaints and conduct documentary investigations to look for any anomaly recorded during production as neither the lot number nor the sample are available.Thus, no investigation can be made for this complaint.However, this complaint will be used for trend analysis.According to the information known, quality database was checked and revealed the field safety notifice fsca_20241119_packaging associated with the corrective and preventive action: capa: 000323 ¿non-conformity of the primary pack on products of multivac 2 machine in dsu value stream on tat-site¿ opened on november 2024.All the products packaged on the multivac 2 machine were recalled on the 5 previous years.The investigation conducts to 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 scope of recall scope.Defect: packaging issue or infection from march 2021 to march 2025: 17 similar cases were found.A rmf evaluation was performed based on criq 247- risk identified 10116 (hazardous situation: lack of sterile barrier properties for primary packaging) we can conclude that the overall residual risk associated with the use of the medical device when weighed against the benefit/risk ratio to the patient / user is not adequately or insufficiently controlled.Necessary actions need to be taken to review the risk mitigation's and to reset the risk criteria in the green area.The harms, severity and occurrence are not within anticipated levels per the risk documentation.A medical assessment was also performed which conclude: the risk of infection appears as moderate but 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, which is likely to develop an infection process if his own immune system or the antibioprophylaxis are not sufficient.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.

• 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 Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 21095652
• Report Number: 9610711-2025-00007
• Device Sequence Number: 8775806
• Product Code: EZL
• UDI-Device Identifier: 03600040995587
• UDI-Public: 03600040995587
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Consumer,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2025

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: AA6108
• Was Device Available for Evaluation?: No
• 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; Not provided
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 11/03/2025; 11/04/2025
• 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: Required Intervention
• Patient Sex: Unknown