MAUDE Adverse Event Report: WELLSPECT HEALTHCARE LOFRIC; LOFRIC NELATON 15CM CH08

Model Number	4040800
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review showed no deviations.No earlier complaints registered for this lot.Witness samples retained by the manufacturer showed no deviations.We are trying to get the product back for investigation.
Event or Problem Description
Product problem occurred outside us, in the republic of korea.User opened the primary packaging of the catheter and discovered the tip was pointed.Only one product was discovered with this problem and the user did not use the product.The user contacted the local distributor and informed about this product problem.
Additional Manufacturer Narrative
Batch review showed no deviations.No earlier complaints registered for this lot.Witness samples retained by the manufacturer showed no deviations.Examination of the returned product shows that the catheter tip is sharp and pinched.The root cause has not been established, but a plausible root cause is that during the packaging operation, the catheter did not fullt seat into the designated cavity of the mold.As a result, part of the catheter tip may remain outside and become compressed between the molding parts, leading to deformation.It was concluded that this was a isolated case sine only one catheter was reported affected.To prevent any future incidents, it was decided to increase the operators awarness by conducting a training.
Event or Problem Description
Product problem occurred outside us, in the republic of korea.User opened the primary packaging of the catheter and discovered the tip was pointed.Only one product was discovered with this problem and the user did not use the product.The user contacted the local distributor and informed about this product problem.

• Brand Name: LOFRIC
• Common Device Name: LOFRIC NELATON 15CM CH08
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; p.o. box 14; mölndal, SE-43 121; SW SE-43 121
• Manufacturer Contact: johanna lundqvist ; aminogatan 1; p.o. box 14; mölndal, SE-43- 121 ; SW SE-43 121
• MDR Report Key: 24516492
• Report Number: 3009632672-2026-00005
• Device Sequence Number: 15892601
• 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,Followup
• Report Date (Section B): 03/17/2026

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
• Device Model Number: 4040800
• Device Catalogue Number: 40408
• Device Lot Number: 661483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2024
• 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: Unknown