MAUDE Adverse Event Report: WELLSPECT HEALTHCARE LOFRIC; CATHETER, STRAIGHT

Model Number	40408
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This complaint occured outside us, in south korea and has been reported to the korean mfds (ministry of food and drug safety).The complaint describes a hair found in the welding strip on the primary package of a urological catheter, between the frontside and backside of the foil.The front side and backside of the foil are welded together to create the single package sterile barrier, protecting the catheter until use.The hair was discovered prior to use and was not in contact with catheter surface which normally has direct body contact.No clinical impact nor harm is reported with this complaint.
Additional Manufacturer Narrative
A similar incident occurred last year (2023) in south korea and was reported to the korean authority (mfds).The affected product at that time was a similar product as defined in this report.The foreign material on the product was discovered prior to use and no clinical impact nor harm was reported for this complaint in 2023.The identified root cause for that complaint was that hair fell to the package due to occasional opening of the wrist of the operator's clean room clothes during placement of the catheter in the molds in front of the packaging machine or hanging the packaging material rolls.The following corrective measures was implemented on july 1, 2023: operators who work at the packaging machine have to wear oversleeve and clean room instruction has been updated accordingly.Re-training of the updated clean room instruction has been conducted to employee who work in the clean room.Re-training of packaging instruction to visual inspection operators after packaging have been performed.Affected product in this report is produced and packed before the corrective measures was implemented in july, 2023.The piece of hair found inside the primary package does not affect the sterility of the product since the hair is stuck in the welding without any gap.The product is sterilized with eo at a later stage, and everything (also a potential foreign particle) is sterilized.The hair is not in direct contact with the catheter surface and has not affected the catheter coating.During activation it's likely that the foreign particle will get in contact with the catheter surface, however it will not be attached to the surface, and it's deemed unlikely that the foreign particle will follow the catheter into the narrow urethral orifice.We don't see any potential health issue related to this deviation since the hair does not follow the catheter surface into the human body.

• Brand Name: LOFRIC
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; p.o.box 14; molndal, 43121 ; SW 43121
• Manufacturer Contact: ulrika skogback ; aminogatan 1; p.o.box 14; molndal, ; SW
• MDR Report Key: 20116476
• Report Number: 3009632672-2024-00011
• Device Sequence Number: 7202944
• Product Code: EZD
• UDI-Device Identifier: 07333387038360
• UDI-Public: 07333387038360
• Combination Product (Y/N): N
• PMA/510(K) Number: K113424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/30/2024

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: Lay User/Patient
• Device Model Number: 40408
• Device Catalogue Number: 4040800
• Device Lot Number: 642862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 09/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2023
• 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