MAUDE Adverse Event Report: COLOPLAST A/S X-FLOW DUFO 3WAY SIL 50ML CH22; CATHETER

Model Number AB63221002

Device Problems Deflation Problem (1149); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2017

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.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, during use, the catheter cut off above the 3 ways "w" junction.After coming back from operative room, patient came back in his bed.The catheter cut just above the 3 ways separation, balloon deflated, vesical catheter stayed in place, was withdrawn by nurse.Patient undwelled too soon, urinary retention risk and clotting, vesical catheter to re-indwelled if needed.Catheter discarded.

• Brand Name: X-FLOW DUFO 3WAY SIL 50ML CH22
• Type of Device: CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: christine buckvold
• MDR Report Key: 6436036
• MDR Text Key: 71214687
• Report Number: 9610711-2017-00011
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040144442
• UDI-Public: 03600040144442
• Combination Product (y/n): N
• PMA/PMN Number: K013172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 03/27/2017

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 Model Number: AB63221002
• Device Catalogue Number: AB63221002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/07/2017
• Initial Date FDA Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1