MAUDE Adverse Event Report: OWEN MUMFORD LIMITED UNISTIK; LANCET

Model Number	AT 1012
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A offending device was not sent back.Investigation consisted of reviewing the batch file and retain samples were reviewed.No anomalies were highlighted that could account for this complaint.No further action could be taken.
Event or Problem Description
Hospital sent email of an issue they had experienced with our lancets.The email stated some of the lancets, device does not retract needle after use.They reported the needle loosely drops out but doesn't remain with the orange base.No other details were provided, nor a sample sent.

• Brand Name: UNISTIK
• Common Device Name: LANCET
• Manufacturer (Section D): OWEN MUMFORD LIMITED; brook hill; woodstock, oxfordshire OX20 1TU; UK OX20 1TU
• MDR Report Key: 21453337
• Report Number: 1058602-2025-00002
• Device Sequence Number: 7289968
• Product Code: FMK
• UDI-Device Identifier: 00384701012013
• UDI-Public: 00384701012013
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2025
• Report Date (Section F): 02/24/2025

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: Health Professional
• Device Model Number: AT 1012
• Device Lot Number: 078401
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/10/2024
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/20/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/24/2025