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

Catalog Number AB6118

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

According to the available information the catheter was observed to have red foreign materials on it.

Event Description

According to the available information the catheter was observed to have red foreign materials on it.

Manufacturer Narrative

After receiving this complaint, we searched for other complaints and we found none regarding the lot number 8765612.Checking the quality databases revealed one non-conformity in relation to the described defect.One used sample was received.Red marks were observed on the catheter.This defect was shown to the workshop manager and with our tunisian subcontractor, this defect cannot be clearly identified, origins of the red mark was still unknown.The investigation from our subcontractor precises that "during cleaning stage this kind of defect must be scrapped.The defect was not detected by the operator during the quality control, this is an error.Action has been taken regarding the presence of foreign bodies.Reinforced checks will be carried out before and after loading the inner pouch.".

• Brand Name: X-FLOW PROSTATECTOMY CATHETER
• Type of Device: INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): CMF-SARLAT; 9 avenue edmond rostand; sarlat-la-caneda ; FR
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18121649
• MDR Text Key: 328149247
• Report Number: 9610711-2023-00245
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040143629
• UDI-Public: 3600040143629
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/13/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: AB6118
• Device Lot Number: 8765612_AB61181002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2023
• Date Device Manufactured: 09/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1