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	04/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical questionnaire received on (b)(6) 2026.
Event or Problem Description
Cardinal health reported to us that one of their customers reported that the needle did not retract and was stuck when picking device up after using.Medical questionnaire received (b)(6) 2026.

• 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: 25247723
• Report Number: 1058602-2026-00007
• Device Sequence Number: 15884047
• 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): 05/21/2026
• Report Date (Section F): 05/21/2026

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: 12661
• 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: 04/21/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2026
• 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: 05/21/2026