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

Catalog Number	AB6A22
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information the user found a hair inside the tubing of the catheter.No adverse event to the patient.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn't find another complaint on the lot number 9055054.Checking the quality databases did not reveal any anomaly in relation to the described defect.Actions have been put in place since april 2021 concerning the presence of hair (reinforced control before and after sheathing and before and after the corking rope) and its actions are carried out until today" in addition, our subcontractor has re-sensitized production operators about "hair presence and decontamination" in september 2023 we have not received sample.Upon receipt complaint will be reopened and updated.Unfortunately without sample from the customer and we cannot go further than the documentary investigation which didn¿t reveal any anomaly recorded during production.
Event or Problem Description
According to the available information the user found a hair inside the tubing of the catheter.No adverse event to the patient.

• 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: 17661689
• Report Number: 9610711-2023-00191
• Device Sequence Number: 17923106
• Product Code: EZL
• UDI-Device Identifier: 03600040145968
• UDI-Public: 3600040145968
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

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: AB6A22
• Device Lot Number: 9055054_AB6A221002
• 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: 08/31/2023
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2023
• 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: Other
• Patient Sex: Unknown