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	03/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Samples just sent for evaluation on 14 apr 2026: investigation still in progress.
Event or Problem Description
Cardinal health reported to us that one of their customers complained that the needle is not discharging/ retracting.

• 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: 24916186
• Report Number: 8021764-2026-00001
• Device Sequence Number: 15724785
• 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?: No
• 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: 03/23/2026
• 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