MAUDE Adverse Event Report: WELLSPECT HEALTHCARE LOFRIC ORIGO; LOFRIC ORIGO NELATON 40CM CH12

Model Number	44312
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Product user (patient) reported that 3 urinary catheters from the same box had a cut at the lower part of the single sterile package.Patient claimed, when he activated the water sachet for wetting of the hydrophilic surface, the fluid flushed out on the floor.It is like a small part of the package has been cut off.The patient used two of the catheters with the same fault but didn't experience any problems during catheterization or afterwards.He did not get a uti or any other medical issues due to this and reports that he is doing fine.
Additional Manufacturer Narrative
One product was returned to the manufacturer, which had compromised sterile barrier.The investigation of the production batch records did not provide conclusion for root cause.No earlier complaint registered for this lot.The welds are inspected in the manufacturing process at every order start, every shift start and every two hours.One product from each position in the machine is inspected.In the final inspection of the product the welds are also inspected prior to release of the lot.Examination of returned sample shows that there is cut over the bottom weld.This cut has not been caused by something in the production line.The products have been damaged after leaving the production.It's not possible to determine where or when.Since no other problems have been found, this is evaluated to be a limited incident.

• Brand Name: LOFRIC ORIGO
• Common Device Name: LOFRIC ORIGO NELATON 40CM CH12
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; p.o.box 14; molndal, SE-43 121; SW SE-43121
• Manufacturer (Section G): WELLSPECT HEALTHCARE; aminogatan 1; p.o.box 14; molndal, SE-43 121; SW SE-43121
• Manufacturer Contact: emad ramzi ; aminogatan 1; molndal, 43151 ; SW 43151
• MDR Report Key: 18737480
• Report Number: 3009632672-2024-00001
• Device Sequence Number: 17876096
• Product Code: EZD
• UDI-Device Identifier: 07333387043319
• UDI-Public: 07333387043319
• Combination Product (Y/N): N
• PMA/510(K) Number: K122078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/20/2024

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 Expiration Date: 06/19/2025
• Device Model Number: 44312
• Device Catalogue Number: 4431220
• Device Lot Number: 645221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White