MAUDE Adverse Event Report: COLOPLAST A/S SILIC 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 6964692.Checking the quality databases revealed no anomaly in connection with the described defect.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.

Event Description

According to the available information, there is a small edge in the tip area of the product, which causes an injury in the mucous membrane when the product was pulled, causing urethral bleeding.

Event Description

Additional information received stated in the operation theatre, when catheter was placed prior to the surgery and was removed when the surgery was finished.No clinical consequence for the patient is reported.

Manufacturer Narrative

Checking the quality databases revealed no anomaly in connection with the described defect.The product reference aa61141002 lot number 6964692 was made with the intermediate product aa611480 lot number 6708997.5 similar cases were found for aa6114.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.The device conforms according to our specifications.It is concluded that the risks identified are still acceptable and considered as safe.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: SILIC FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9945276
• MDR Text Key: 187103996
• Report Number: 9610711-2020-00012
• 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: 07/23/2020

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: 6964692
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 04/09/2020
• Supplement Dates Manufacturer Received: 03/11/2020
• 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