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

Model Number	789789789
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn¿t found any other complaint on lot 9888960.The investigation is not yet complete, a follow up report will be submitted on completion of the investigation.B3: estimated date.
Event or Problem Description
According to the available information, presence of hair was in the sterile packaging.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn¿t found any other complaint on lot 9888960.On february 24, 2025, we informed our hungarian site about the issue.An investigation was performed which conclude: potential root cause was an accidentally issue contamination done during packaging step or raw material was arrived contaminated.Operators have not detected the hair then the product have packaged and shipped out to the market.All involved employees have been informed from this issue, they will focus to filter out the hair infected pouches all the time at production order starting to avoid reoccurrence claims in the future.Without sample we cannot observe the defect and determine at which stage the contamination occurred.Checking the quality databases revealed no anomaly in connection with the described defect.
Event or Problem Description
According to the available information, presence of hair was in the sterile packaging.

• 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: 21496953
• Report Number: 9610711-2025-00042
• Device Sequence Number: 7158561
• Product Code: EZL
• UDI-Device Identifier: 03600040144312
• UDI-Public: 3600040144312
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 07/09/2025

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 Model Number: 789789789
• Device Catalogue Number: AB6320
• Device Lot Number: 9888960_AB63201002
• Was Device Available for Evaluation?: No
• 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: 02/28/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2024
• 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