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	Serious Injury
Additional Manufacturer Narrative
The lancet in question was not returned and 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.No 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 futher complaints of this nature.
Event or Problem Description
Nurse was taking 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 sharps container.

• Brand Name: UNISTIK 3
• Common Device Name: LANCET
• Manufacturer (Section D): OWEN MUMFORD LIMITED; brook hill; woodstock, oxfordshire OX20 1TU; UK OX20 1TU
• MDR Report Key: 17192291
• Report Number: 1058602-2023-00003
• Device Sequence Number: 5869528
• Product Code: FMK
• UDI-Device Identifier: 00384701044014
• UDI-Public: 00384701044014
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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): 06/23/2023
• Report Date (Section F): 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
• Operator of Device: Health Professional
• Device Model Number: AT 1044
• Device Lot Number: 070092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/23/2023
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/25/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2023
• 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 Age: 24 YR
• Patient Sex: Female
• Date Report Sent to FDA: 06/23/2023