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

Catalog Number	AA6114
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	11/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is not yet complete, a follow up report will be submitted on completion of the investigation.B3: estimated date.D4: potential lots: 8948148 & 8975016.
Event or Problem Description
According to the available information, the patient has been having ongoing issues with bladder infections with her catheter from (b)(6) 2023 - the spring of 2024.The patient has been cathing and using catheters for 26 years without incident but their infections have become so constant and persistent that they have hit antibiotic resistance after numerous courses of antibiotics.The patient has undergone ct scans and renal scans that have all been normal.The patient will be having a cystoscopy to verify that nothing is inside their bladder causing these recurrent infections.Patient is currently doing antibiotics flush directly into their bladder with a catheter daily to prevent infection.
Event or Problem Description
According to the available information, the patient has been having ongoing issues with bladder infections with her catheter from (b)(6) 2023 - (b)(6) 2024.The patient has been cathing and using catheters for 26 years without incident but their infections have become so constant and persistent that they have hit antibiotic resistance after numerous courses of antibiotics.The patient has undergone ct scans and renal scans that have all been normal.The patient will be having a cystoscopy to verify that nothing is inside their bladder causing these recurrent infections.Patient is currently doing antibiotics flush directly into their bladder with a catheter daily to prevent infection.
Additional Manufacturer Narrative
According to the information known, quality database was checked and revealed the field safety notice 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 (b)(6) 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 (b)(6) 2021 to (b)(6) 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 mitigations 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: 21357135
• Report Number: 9610711-2025-00028
• Device Sequence Number: 8464872
• Product Code: EZL
• UDI-Device Identifier: 03600040127360
• UDI-Public: 3600040127360
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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
• Device Lot Number: 8975016_AA61141002
• Is the Reporter a Health Professional?: No
• 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: 02/11/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown