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

Model Number AB61221002

Device Problem No Flow (2991)

Patient Problem Pain (1994)

Event Date 12/17/2014

Event Type  malfunction  

Event Description

According to the information received, 2.5 hours following catheter insertion, the patient noted no urine flow.He experienced slight pain due to the blocked urine flow but he did not suffer any harm because he went to the reportinghospital for a catheter exchange.No further information available.

Manufacturer Narrative

Coloplast received 1 used device.Failure type was determined to be drainage which is consistent with reported complaint.Known issue.

• Brand Name: X FLOW DUFO 3WAY SIL 50ML CH22
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING FRANCE SAS; 9 avenue edmond rostand; sarlat-la-canéda, 2420 6; FR 24206
• Manufacturer Contact: megan daniel ; 1601 w river rd n; minneapolis, MN 55411 ; 6123024930
• MDR Report Key: 4600809
• MDR Text Key: 5464362
• Report Number: 9610711-2015-00002
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K013172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2015

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: Lay User/Patient
• Device Expiration Date: 06/27/2019
• Device Model Number: AB61221002
• Device Catalogue Number: AB61221002
• Device Lot Number: 4030359
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/08/2015
• Initial Date FDA Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1