MAUDE Adverse Event Report: WELLSPECT HEALTHCARE LOFRIC; LOFRIC NELATON 40CM CH14

Model Number	40014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The batch documentation for the affected device has been reviewed and no deviation was found on the released batch.Furthermore, before each batch release a 100% routine visual control of the device package was performed without any remarks.In addition, to the visual control and the batch documentation, witnessed samples from the same lot have been examined and no deviation on the catheter tip was found.At this moment manufacturer concludes that this is an isolated event.
Event or Problem Description
This incident occured outside united state.According to the patinet the catheter tip was gnarled and deformed, especially the tip described as needle-sharp.When using the catheter, the patient injured himself so much that he bled.The patient has not made a doctor's visit and has also continued catheterization since the injury occurred on 2024-03-23 as the bleeding was not long-lasting.

• Brand Name: LOFRIC
• Common Device Name: LOFRIC NELATON 40CM CH14
• 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, molndal SE-43-121 ; SW SE-43121
• MDR Report Key: 19123071
• Report Number: 3009632672-2024-00002
• Device Sequence Number: 8248927
• Product Code: EZD
• UDI-Device Identifier: 07333387033730
• UDI-Public: 07333387033730
• 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): 04/16/2024

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: 40014
• Device Catalogue Number: 4001400
• Device Lot Number: 648734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (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