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

Catalog Number	AB6022
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and found one other complaint regarding the lot number 9558657 on the same defect (b)(4).
Event or Problem Description
According to the available information, while inside the or a hair was found wrapped in the sterile package.The hair is not loose in the sterile packaging but is in the packaging of the catheter itself.The packaging was not opened.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we find one other complaint regarding the lot number 9558657 on the same defect (b)(4).With the picture attached, we can see the hair in the first pouch "waffle sheath".The catheter is packaged in this sheath par by our tunisian subcontractor which was informed about this issue.On 27th december we received investigation from our subcontractor: "the operators have not detected the hair.Reinforced control actions have been put in place to properly control the products before and after sheathing to avoid this issue occurred again".In addition, our subcontractor has re-sensitized production operators about "hair presence" in november 2024.Checking quality database reveled no anomaly in relation to the described problem.The evaluation has showed that risks are adequately controlled and reduced as far as possible in the state of art.Based on this, we can conclude that residual risks are adequately controlled and reduced as far as possible, and the residual risks associated with the use of the product are acceptable when weighed against the benefits to the patient/user.It is concluded that the risks identified are still acceptable and considered as safe.
Event or Problem Description
According to the available information, while inside the or a hair was found wrapped in the sterile package.The hair is not loose in the sterile packaging but is in the packaging of the catheter itself.The packaging was 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: 20592285
• Report Number: 9610711-2024-00306
• Device Sequence Number: 18343906
• Product Code: EZL
• UDI-Device Identifier: 03600040143360
• UDI-Public: 3600040143360
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AB6022
• Device Lot Number: 9558657_AB60221002
• 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: 11/01/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• 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