MAUDE Adverse Event Report: OWEN MUMFORD LIMITED 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 rand retain 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 LIMITED; brook hill; woodstock, oxfordshire OX20 1TU; UK OX20 1TU
• Manufacturer (Section G): OWEN MUMFORD SDN BHD; no. 19, 21, jalan biotknologi; kawasan perindustrian silc; iskandar puteri, johor 79200 ; MY 79200
• Manufacturer Contact: patty haney ; 1755 west oak commons ct.; marietta, GA 30062 ; 7709772226
• MDR Report Key: 23549364
• Report Number: 8021764-2025-00005
• Device Sequence Number: 15835402
• Product Code: FMI
• UDI-Device Identifier: 50885380025844
• UDI-Public: 50885380025844
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K221126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2025
• 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: Other
• Patient Sex: Female