MAUDE Adverse Event Report: OWEN MUMFORD LIMITED UNISTIK TOUCH; BLOOD LANCET

Model Number	AT 1414
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for assessment.Batch file review did not highlight any anomalies that could account for this complaint.No further action can be taken at this time.
Event or Problem Description
Hospital reported to medsum that when taking the patient's blood sugar, lancet used did not retract.When removed away from patient, needle exposed and penetrated through glove resulting in needle stick.

• Brand Name: UNISTIK TOUCH
• Common Device Name: BLOOD 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 cronan ; 1755 west oak commons ct.; marietta, GA 30062 ; 7709772226
• MDR Report Key: 15407205
• Report Number: 8021764-2022-00005
• Device Sequence Number: 15191708
• Product Code: FMK
• UDI-Device Identifier: 00384701414015
• UDI-Public: 00384701414015
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K222111
• 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): 09/12/2022

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: 08/05/2026
• Device Model Number: AT 1414
• Device Lot Number: 2108021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown