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

Catalog Number	AA6106
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: estimated date.
Event or Problem Description
According to the available information, the pediatric catheters broke off on two occasions right at the portion where the catheter bag connector and the shaft of the catheter meets.It broke off in the patient and patient had to be taken to theatre for removal.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and one other complaint on the lot number 9429228 on the same defect ((b)(4)).According to the investigation performed quality databases was checked and reveal no anomaly in relation to the described defect.On 2nd september, we receive one used sample.We have only received the connector part, the cut is clean and no trace of tape is present on the sample.The root cause was probably due to a lack of securisation.
Event or Problem Description
According to the available information, the pediatric catheters broke off on two occasions right at the portion where the catheter bag connector and the shaft of the catheter meets.It broke off in the patient and patient had to be taken to theatre for removal.

• 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: 20191536
• Report Number: 9610711-2024-00243
• Device Sequence Number: 7002790
• Product Code: EZL
• UDI-Device Identifier: 03600040126844
• UDI-Public: 3600040126844
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AA6106
• Device Lot Number: 9429228_AA61061002
• 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: 09/11/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2023
• 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