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

Model Number	AT 6201
Medical Device Problem Codes	Retraction Problem (1536); Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The batch file has been reviewed with no anomalies noticed.Lot number 12743 originated from lancet batch 12234.This is a similar complaint received investigated under complaint (b)(4).Retention samples were tested and all devices were able to be discharged and no device non-retraction symptoms or other abnormalities were identified.The conclusion was that the review of batch file records and retention samples do not show any abnormality that can contribute to the complaint defect.If there is a sample received, omm will re-open the complaint and investigate on the returned samples.As of now, no action is required.Omm will continue to monitor if there are any similar complaints in the future.
Event or Problem Description
Cardinal health reported to us that one of their customers reported there have been 3 cases of needlestick injury during use of this product.Both issues have occurred: 1.Not firing (discharging) after top is twisted off.2.After firing (discharging) the needles is still exposed (not retracting).Pt code: 4559 device codes: 1536, 2532.

• 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: 25460511
• Report Number: 8021764-2026-00008
• Device Sequence Number: 10348030
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2026

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: 12743
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2025
• 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