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 uner 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 conplaint 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
• MDR Report Key: 25460515
• Report Number: 1058602-2026-00008
• Device Sequence Number: 10362882
• Product Code: FMK
• UDI-Device Identifier: 20885380025843
• UDI-Public: 20885380025843
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/10/2026
• Report Date (Section F): 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
• Was the Report Sent to FDA?: Yes
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2026
• 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: Unknown
• Date Report Sent to FDA: 06/10/2026