MAUDE Adverse Event Report: OWEN MUMFORD LIMITED UNIFINE PENTIPS; PEN NEEDLES

Model Number	AN 3530
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Anxiety (2328)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient called to state she was injecting her insulin and when she finished, she pulled out the pen and that the needle was not attached.

• Brand Name: UNIFINE PENTIPS
• Common Device Name: PEN NEEDLES
• Manufacturer (Section D): OWEN MUMFORD LIMITED; brook hill; woodstock, oxfordshire OX20 1TU; UK OX20 1TU
• MDR Report Key: 11208020
• Report Number: 1058602-2021-00001
• Device Sequence Number: 14298455
• Product Code: FMI
• UDI-Device Identifier: 00384703530010
• UDI-Public: 00384703530010
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/19/2021
• Report Date (Section F): 01/19/2021

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: Lay User/Patient
• Device Expiration Date: 10/01/2021
• Device Model Number: AN 3530
• Device Catalogue Number: AN3530
• Device Lot Number: 1910737
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/07/2020
• Device Age: 14 MO
• Event Location: Home
• Date Report to Manufacturer: 01/20/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/21/2021
• 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: 45 YR
• Patient Weight: 139
• Date Report Sent to FDA: 01/19/2021