MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL SILICONE CATHETER - LONG-TERM; INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL

Catalog Number AA8512

Device Problems Delivered as Unsterile Product (1421); Device Appears to Trigger Rejection (1524); Contamination /Decontamination Problem (2895)

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.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 available information, this device had what appeared to be a piece of fiber in it.It was found before use.No other adverse patient effects were reported.

Manufacturer Narrative

After receiving this complaint, we searched for other complaints and we found none regarding the lot number 8865455.Checking the quality database according with elements known revealed no anomaly in relation to the describe defect.Hungary's site made an investigation about this issue with the pictures provided and identified 2 possibles causes for hair in packaging: 1.Operators in the production didn't notice the hair on the catheter.There is a visual inspection in the process to detect this type of failure.The issue was not detected by this control.2.Recent investigations found that hair complaints can be traced back to the tunisian supplier.The catheter was already received with the hair.Operators have been retrained and we have notified tunisia about the hairs found in the packaging.

Event Description

According to the available information, a hair was found in the packaging on a folysil product.

• Brand Name: FOLYSIL SILICONE CATHETER - LONG-TERM
• Type of Device: INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): CMF-SARLAT; 9 avenue edmond rostand; sarlat-la-caneda ; FR
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 17412578
• MDR Text Key: 319922825
• Report Number: 9610711-2023-00151
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040133842
• UDI-Public: 3600040133842
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

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 Catalogue Number: AA8512
• Device Lot Number: 8865455_AA85121002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1