MAUDE Adverse Event Report: OWEN MUMFORD LIMITED UNISTIK TOUCH; LANCETS

Model Number	AT 1424
Medical Device Problem Codes	Fail-Safe Problem (2936); Protective Measures Problem (3015); Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Codes	Anxiety (2328); Needle Stick/Puncture (2462)
Date of Event	03/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Technician was putting used lancet into sharps bin after testing patient when accidental prick occurred.
Additional Manufacturer Narrative
The devices were not returned for evaluation.A batch file review did not highlight any abnormalities with this batch during production.100 samples from this batch were functionally tested with no faults identified; all lancets retracted as intended.Two photographs were forwarded retrospectively, which depicted the lancets sticking out of the device bodies.Without the actual product, the root cause could not be determined.

• Brand Name: UNISTIK TOUCH
• Common Device Name: LANCETS
• Manufacturer (Section D): OWEN MUMFORD LIMITED; brook hill; woodstock, oxfordshire OX20 1TU; UK OX20 1TU
• MDR Report Key: 8557813
• Report Number: 8021764-2019-00006
• Device Sequence Number: 16899135
• Product Code: FMK
• UDI-Device Identifier: 00384701424014
• UDI-Public: 384701424014
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/28/2019
• Report Date (Section F): 04/26/2019

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 Expiration Date: 06/20/2020
• Device Model Number: AT 1424
• Device Lot Number: 160565
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/04/2019
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2019
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 06/28/2019
• 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
• Date Report Sent to FDA: 04/26/2019