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

Catalog Number	AA6318
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we found none regarding the lot number 9453643.B3: estimated date.
Event or Problem Description
According to the available information upon opening the secondary packaging, a hair was noticed in the catheter's primary packaging.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we found none regarding the lot number 9453643.Checking the quality databases revealed no anomaly in relation to the describe defect.Our hungarian site performed its investigation: the potential root causes identified: - this is an accidentally issue, during the production and packaging process, the hair can be gone into 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.Action(s): - all involved employees have been informed from 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.- continuously inform the supplier about the affected lots to improve their processes, if the received lots affected by hair contamination.In addtion our supplier, who sends the raw material to our hungarian site, has re-sensitized production operators about "hair presence" in november 2024 and about a good manufacturing practise in may 2024.
Event or Problem Description
According to the available information upon opening the secondary packaging, a hair was noticed in the catheter's primary packaging.

• 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 Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 19816458
• Report Number: 9610711-2024-00189
• Device Sequence Number: 8694682
• Product Code: EZL
• UDI-Device Identifier: 03600040128909
• UDI-Public: 03600040128909
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K233411
• 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): 03/12/2025

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: 9453643_AA63181002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2023
• 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