MAUDE Adverse Event Report: COLOPLAST A/S FOLEY CATHETER

Model Number AA61141002

Device Problem Sharp Edges (4013)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

After receiving this complaint, we searched for other complaint and we didn't find other complaint on the lot number 7210726.Checking the quality databases revealed no anomaly in connection with the described defect.Unfortunately no sample is available from the customer and we cannot go further than the documentary investigation which didn't reveal any anomaly recorded during production.Should additional facts prompt us to alter or supplement any information or 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, the catheter caused a urethral hemorrhage when it was pulled, there is a small edge in the tip area which caused this.

Manufacturer Narrative

We received 1 used sample -at the first inspection, we see the tip broken with burrs, and acceptable according to our specification.The burrs are of 1mm and soft.It is concluded that the risks identified are still acceptable and considered as safe.5 similar cases were found since ce marking for aa6114 with burr.Our clinical assessment concluded : catheterization with foley catheters is a common urological procedure.This type of medical device must only be used by trained and experienced professionals.The professionals should particularly check the catheter and balloon (by inflation/deflation) before use.Such incident is possibly in favor of a product defect.

• Brand Name: FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9991982
• MDR Text Key: 188705053
• Report Number: 9610711-2020-00013
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040127360
• UDI-Public: 03600040127360
• Combination Product (y/n): N
• PMA/PMN Number: K013174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AA61141002
• Device Catalogue Number: AA6114
• Device Lot Number: 7210726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Manufacturer Received: 03/24/2020
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 03/24/2020
• Supplement Dates FDA Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other