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

Model Number	44414
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation on batch documentation shows no deviations connected to the reported product issue.The visual inspection performed on the returned products shows that the 24 samples checked from the 12 customer boxes (unopened) had no damages on the catheter package.However, the returned loose catheter (20 pieces) shows that the catheter package had a missing weld closest to the tip of the catheter.The opening (missing weld) was estimated to be approximately 1,3 cm wide.Primary packaging control are carried out at the start of an order and at the start of the shift, as well as once per hour, where welds and dimensions are checked.In the final inspection of the product the welds are also inspected prior to release of the lot.No faulty products were found in these controls and no other complaint with this failure mode has been registered for this lot.Root cause could not be established.However, possible explanation could be that a manual feed in production line has been carried out without discarding the products in the machine.This has led to the machine not running its full stroke, which has caused the products to end up in the wrong position and the weld has been cut off.Therefore we believe this is an isolated incident.Should additional facts prompt us to alter or supplement any information of conclusions contained in this report, a follow-up report to this final report will be submitted.
Event or Problem Description
Product problem occurred outside us, in the netherlands.A male user of lofric origo tiemann 40cm ch14 (sterile single-use intermittent urinary catheter) discovered prior to use that the primary package of the catheter was damaged.The primary package (sterile barrier) had a missing weld at the lower end of the packaging.The product were not used and no harm or medical complication were reported.Several attempts to contact user have been made to gather further information about the malfunction of this device but with no result.The affected catheters was returned to manufacturer for investigation.

• Brand Name: LOFRIC ORIGO
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; p.o.box 14; molndal, SE-43 1 21; SW SE-431 21
• Manufacturer Contact: ulrika skogbäck ; aminogatan 1; p.o.box 14; molndal, SE-43-1 21 ; SW SE-431 21
• MDR Report Key: 21331894
• Report Number: 3009632672-2025-00005
• Device Sequence Number: 8062942
• Product Code: EZD
• UDI-Device Identifier: 07333387043432
• UDI-Public: 07333387043432
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2025

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: Lay User/Patient
• Device Expiration Date: 08/08/2026
• Device Model Number: 44414
• Device Catalogue Number: 4441465
• Device Lot Number: 658990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2024
• 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: Male