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

Catalog Number AA6314

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2023

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 was not able to be used due to a hair.There was a hair in the packaging before it was opened.

Event Description

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

Manufacturer Narrative

After receiving this complaint, we searched for other complaint and we didn¿t find other complaint on the lot n°8710097.Checking the quality databases revealed no anomaly in connection with the described defect.There are 2 possible 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 we receive catheters with hair already on them.We trained the operators about this kind of failure and the importance of wearing hair net in the production.We also contacted the tunisian supplier regarding the hairs inside the packages in catheters.

• Brand Name: FOLYSIL SILICONE CATHETER
• 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: 17375851
• MDR Text Key: 319563702
• Report Number: 9610711-2023-00144
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040128640
• UDI-Public: 3600040128640
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K013174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Nurse
• 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 Operator: Health Professional
• Device Catalogue Number: AA6314
• Device Lot Number: 8710097_AA63141002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2022
• 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