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	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we didn't find other complaints on the lot number 9863022.B3: estimated date.
Event or Problem Description
According to the available information, as the hospital opened a package there was a hair (possibly eyebrow or lash) inside one of the sterile packages.The package was sealed and not opened.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we didn't find other complaint on the lot number 9863022.On march 19th 2025, no sample or picture was received, so we cannot determine exactly at which stage of production the product was contaminated.The catheter is packaged in this sheath by our tunisian subcontractor which was informed about this issue.Our subcontractor has re-sensitized production operators about "hair presence" in november 2024 and about good manufacturing practise in may 2024.The primary packaging was made by our hungary's site which was informed about this issue.Our hungarian site performed its investigation: the issue was caused by a human failure.So the action is: all involved employees have been retrained.The operators are aware of the rules, the mistake was caused by inattention.Checking the quality databases revealed no anomaly in connection with the described defect.
Event or Problem Description
According to the available information, as the hospital opened a package there was a hair (possibly eyebrow or lash) inside one of the sterile packages.The package was sealed and not opened.

• 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: 21116419
• Report Number: 9610711-2025-00011
• Device Sequence Number: 20701561
• Product Code: EZL
• UDI-Device Identifier: 03600040144442
• UDI-Public: 3600040144442
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 04/28/2025

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: 9863022_AB63221002
• 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: 01/09/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2024
• 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