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

Model Number	AT 1444
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	06/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical questionnaire sent to hospital for additional information, but was never received.Followed up three times to obtain the medical questionnaire.
Event or Problem Description
Hospital called sales rep to report that a caregiver on 10 west was accidentally stuck after sticking the patient, when the needle did not retract.They did not save the lancet in question, it went into the sharps.The floor manager said they did not know the lot number of the lancet because they empty the lancets from the box they come in, into a purple holder bin and then discard the box.

• Brand Name: UNISTIK TOUCH
• Common Device Name: LANCET
• Manufacturer (Section D): OWEN MUMFORD LIMITED; brook hill; woodstock, oxfordshire OX20 1TU; UK OX20 1TU
• MDR Report Key: 15213756
• Report Number: 1058602-2022-00003
• Device Sequence Number: 2200006
• Product Code: FMK
• UDI-Device Identifier: 00384701444012
• UDI-Public: 00384701444012
• 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): 08/11/2022
• Report Date (Section F): 08/11/2022

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 1444
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/24/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2022
• 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 Sex: Unknown
• Date Report Sent to FDA: 08/11/2022