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

Model Number	AT 1044
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lancet in question was not returned nad was not available for investigation.A batch file review and retain sample review was performed and did not highlight any anomalies that could account for the stated issue.59 complaints have been received for this product platform over the last 36 months.Nor further complaints have been received for these lot numbers.21 complaints have been confirmed including one complaint of a similar nature.The remaining confirmed complaints are for various concerns including transport damages, packaging and supplier issues.Owen mumford will continue to monitor for any further complains of this nature.
Event or Problem Description
Nurse was takin a glucose check on a patient using the unistik lancet.The nurse placed the lancet on the bed to use the scanner to check the glucose.When she picked up the lancet from the bed, she felt a poke in her finger.On the outside of her glove where the poke was felt, she noticed there was some blood.The lancet in question was disposed of in the hsarps container.

• 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: 17192297
• Report Number: 8021764-2023-00003
• Device Sequence Number: 14920118
• Product Code: FMK
• UDI-Device Identifier: 00384701044014
• UDI-Public: 00384701044014
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2023

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?: No
• Device Model Number: AT 1044
• Device Lot Number: 070092
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 24 YR
• Patient Sex: Female