MAUDE Adverse Event Report: COLOPLAST A/S X-FLOW CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number AB63181002

Device Problems Contamination /Decontamination Problem (2895); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Type  malfunction  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to the available information, a hair was found on the primary packaging of the device.The device was not used.

Manufacturer Narrative

Visual examination of the returned product revealed a hair inside the embossed sheath.

• Brand Name: X-FLOW CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 12257870
• MDR Text Key: 264469442
• Report Number: 9610711-2021-00052
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040144183
• UDI-Public: 03600040144183
• Combination Product (y/n): N
• PMA/PMN Number: K013172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AB63181002
• Device Catalogue Number: AB6318
• Device Lot Number: 7647549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1