MAUDE Adverse Event Report: COLOPLAST A/S X-FLOW PROSTATECTOMY CATHETER; INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL

Catalog Number	AB6322
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information dirt was found inside the packaging.The device was not replaced.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn't find other complaint regarding the lot number 9959395.The investigation is not yet complete, a follow up report will be submitted on completion of the investigation.
Event or Problem Description
According to the available information dirt was found inside the packaging.The device was not replaced.
Additional Manufacturer Narrative
On august2025, we received two sealed samples.In one of them, there is a hair in the waffle sheath.In the other one, there is a particle maybe a particule of a carton on the catheter in the waffle sheath.After receiving this complaint, we searched for other complaint and we didn't find other complaint regarding the lot number 10118389.Checking quality database revealed no anomaly in connection with the described problem.Our subcontractor has re-sensitized production operators about "hair presence" in november 2024.

• Brand Name: X-FLOW PROSTATECTOMY 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: 22235743
• Report Number: 9610711-2025-00096
• Device Sequence Number: 8027002
• Product Code: EZL
• UDI-Device Identifier: 03600040144442
• UDI-Public: 3600040144442
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: AB6322
• Device Lot Number: 10118389_AB63221002
• 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
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2024
• 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