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

Catalog Number	AA6318
Medical Device Problem Code	Device Contaminated at the User Facility (4064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information a hair was found in the sealed packaging.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we didn¿t find other complaints on the lot number 9351828.Checking the quality databases revealed no anomaly in connection with the described defect.Sometimes we receive raw materials from our suppliers with the hair already part in the pouch.The affected materials have been rejected by us.The quality alert has always been sent to the supplier.During the production and packaging process, the hair can enter the packaging.Second, supplier related issue, the raw material have arrived with already polluted by hair.Third, human inattention, the operators have not detected the hair then the product have packaged and shipped out to the market.All involved employees have been informed of this issue, they will focus to filter out the hair infected pouches all the time at production order starting to avoid reoccurrence claims in the future.

• Brand Name: FOLYSIL SILICONE CATHETER
• Common Device Name: 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: 18464423
• Report Number: 9610711-2024-00009
• Device Sequence Number: 11509130
• Product Code: EZL
• UDI-Device Identifier: 03600040128909
• UDI-Public: 3600040128909
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K013174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: AA6318
• Device Lot Number: 9351828_AA63181002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown