MAUDE Adverse Event Report: OWEN MUMFORD LIMITED PENTIPS; PEN NEEDLE

Model Number	AN 3450
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A medical questionnaire was sent to get more information, however, it was never returned.We followed up with the patient/ customer three times trying to get it returned.On each occasion the patient agreed she would send it back, but it never came.
Event or Problem Description
Customer's boyfriend called to report the day after.He communicated that his girlfriend gave herself an injection and when she went to pull it out, the needle broke off in her skin.She went to the er and they were able to remove it.She does not have the pen needle hub or the pen needle they removed to send back.

• Brand Name: PENTIPS
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): OWEN MUMFORD LIMITED; brook hill; woodstock, oxfordshire OX20 1TU; UK OX20 1TU
• MDR Report Key: 17406457
• Report Number: 1058602-2023-00005
• Device Sequence Number: 17981452
• Product Code: FMI
• UDI-Device Identifier: 00384703450011
• UDI-Public: 00384703450011
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/27/2023
• Report Date (Section F): 07/27/2023

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 Model Number: AN 3450
• Device Lot Number: 2112738
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/30/2023
• Device Age: 29 MO
• Event Location: Home
• Date Report to Manufacturer: 06/30/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2023
• 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: 56 YR
• Patient Sex: Female
• Date Report Sent to FDA: 07/27/2023