MAUDE Adverse Event Report: OWEN MUMFORD SDN BHD UNISTIK MEDIUM FLOW; LANCET

Model Number	AT 6201
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	10/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no product returned for investigation.A batch file and retained sample review did not highlight any anomalies that could account for the complaint issue.There have been 60 complaints received for this product platform in the last 36 months.15 complaints have been confirmed, including labelling, packaging and transport damage.No other complaints have been reported for this lot number.No further action can be taken at this time.
Event or Problem Description
Cna used lancet on patient and set down lancet to complete blood sugar.Upon gathering up supplies used, cna was stuck with the patient's used lancet because it did not retract after used.

• Brand Name: UNISTIK MEDIUM FLOW
• Common Device Name: LANCET
• Manufacturer (Section D): OWEN MUMFORD SDN BHD; no. 19, 21, jalan biotknologi; kawasan perindustrian silc; iskandar puteri, johor 79200 ; MY 79200
• MDR Report Key: 23549398
• Report Number: 1058602-2025-00005
• Device Sequence Number: 9327208
• Product Code: FMI
• UDI-Device Identifier: 50885380025844
• UDI-Public: 50885380025844
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2025
• Report Date (Section F): 11/13/2025

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: Health Professional
• Device Model Number: AT 6201
• Device Lot Number: 11485
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/13/2025
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2025
• 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: Female
• Date Report Sent to FDA: 11/13/2025