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

Model Number	AT 1014
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Pct was giving patient blood sugar check and when going to put the lancet in the sharps container the needle would not retract and stuck pct's finger.Nurse manager put lancet in specimen container and the needle did eventually retract with some movement.It appears there was an issue with the safety mechanism.The pct cleaned the site and did not need care.

• Brand Name: UNISTIK 3
• Common Device Name: LANCET
• Manufacturer (Section D): OWEN MUMFORD LIMITED; brook hill; woodstock, oxfordshire OX20 1TU; UK OX20 1TU
• Manufacturer (Section G): OWEN MUMFORD LIMITED; brook hill; woodstock, oxfordshire OX20 1TU; UK OX20 1TU
• Manufacturer Contact: patty haney ; 1755 west oak commons ct.; marietta, GA 30062 ; 7709772226
• MDR Report Key: 20431112
• Report Number: 8021764-2024-00009
• Device Sequence Number: 8488111
• Product Code: FMK
• UDI-Device Identifier: 00384701014017
• UDI-Public: 00384701014017
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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 1014
• Device Lot Number: 081816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown