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

Model Number	AT 1014
Medical Device Problem Codes	Fail-Safe Problem (2936); Protective Measures Problem (3015); Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	Anxiety (2328)
Date of Event	09/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Head nurse of (b)(6) stated another nurse reported to her that she was almost stuck with an exposed lancet because it did not retract after testing a patient.
Additional Manufacturer Narrative
Investigation was opened on 25 sep 2018 to cover several complaints over a 2 month period stating that unistik 3 comfort device needles were not retracting after use.Full report attached ((b)(4)).

• Brand Name: UNISTIK 3 EXTRA
• Common Device Name: LANCET
• Manufacturer (Section D): OWEN MUMFORD LIMITED; brook hill; woodstock, oxfordshire OX20 1TU; UK OX20 1TU
• MDR Report Key: 7963167
• Report Number: 8021764-2018-00008
• Device Sequence Number: 13873574
• Product Code: FMK
• UDI-Device Identifier: 00384701014017
• UDI-Public: 00384701014017
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2019
• Report Date (Section F): 10/12/2018

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 Expiration Date: 03/01/2021
• Device Model Number: AT 1014
• Device Lot Number: L3796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/20/2018
• Device Age: 29 MO
• Event Location: Other
• Date Report to Manufacturer: 09/20/2018
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/12/2018