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

Model Number	44414
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	04/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A patient received a urinary catheter of the wrong size (smaller than required with a curved tip), which led to minor bleeding and required emergency care.The patient has since recovered.The investigation concluded that there was no issue with the functionality of the catheter itself, and the product was manufactured correctly and met all quality standards.The error occurred at the distribution level of the local wholesaler, where they mis-picked the wrong catheter type and shipped it to the patient.The incident's root cause was a human error during the picking and packing process at the wholesaler's warehouse.The wrong catheter size was selected and shipped to the patient.The wholesaler has reviewed their picking and packing procedures to ensure accuracy and is implementing additional checks to avoid the recurrence of incorrect packaging.
Event or Problem Description
A male patient was sent a urinary catheter of the wrong size (smaller than required with a curved tip) by mistake.Patient discovered the mistake and requested an expedite of the correct catheter.The use of wrong catheter led to a minor bleeding and patient visited the er to have this checked out.Everything was fine and patient has recovered.The error occurred at the distribution level of the local wholesaler, where they mis-picked the wrong catheter type and shipped it to the patient.

• Brand Name: LOFRIC ORIGO
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; p.o.box 14; molndal, SE-43 121; SW SE-43121
• Manufacturer Contact: ulrika skogbäck ; aminogatan 1; p.o.box 14; molndal, SE-43-121 ; SW SE-43121
• MDR Report Key: 21917255
• Report Number: 3009632672-2025-00013
• Device Sequence Number: 9031728
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 44414
• Device Catalogue Number: 4441440
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization
• Patient Sex: Unknown