MAUDE Adverse Event Report: OWEN MUMFORD LIMITED CARDINAL HEALTH UNISTIK 3 NORMAL; LANCET

Model Number	AT 6201
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Samples just sent for evaluation on 14 apr 26: investigation still pending.Hospital reported to (b)(6) that the needle stick had no significant injury, only a small needle stick to her ring finger.It did however expose her to potential pathogens from the patient she used the lancet on.All testing was negative on the patient (b)(6), so the employee decided to not seek any treatment.No medications were needed.She did not miss any work and is doing well.
Event or Problem Description
Cardinal health reported to us that one of their customers complained that the needle is not discharging/ retracting and a staff member was stuck by the lancet after use.

• Brand Name: CARDINAL HEALTH UNISTIK 3 NORMAL
• Common Device Name: LANCET
• Manufacturer (Section D): OWEN MUMFORD LIMITED; primsdown industrial estate; worcester rd.; chipping norton, oxfordshire OX7 5 XP; UK OX7 5XP
• Manufacturer (Section G): OWEN MUMFORD SDN BHD; no. 19 & 21, jalan bioteknolog; kawasan peridustrian silc; iskandar puteri, johor 79200 ; MY 79200
• Manufacturer Contact: patty haney ; 1755 west oak commons ct.; marietta, GA 30062 ; 7709772226
• MDR Report Key: 24916180
• Report Number: 8021764-2026-00003
• Device Sequence Number: 13033092
• Product Code: FMK
• UDI-Device Identifier: 20885380025843
• UDI-Public: 20885380025843
• 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: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: AT 6201
• Device Lot Number: 12648
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown