MAUDE Adverse Event Report: OWEN MUMFORD LIMITED UNIFINE PENTIP; PEN NEEDLE

Model Number	AN 3540KRO
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer stated the needle broke off in her stomach during her morning injection.She further stated she was able to pull the needle out of her stomach, but it was painful.She didn't save the broken piece from her stomach, but did save the pen needle hub.She has not gone to the doctor and reported that she watched the site and did not go to the emergency room.

• Brand Name: UNIFINE PENTIP
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): OWEN MUMFORD LIMITED; brook hill; woodstock, oxfordshire OX20 1TU; UK OX20 1TU
• MDR Report Key: 16526432
• Report Number: 1058602-2023-00002
• Device Sequence Number: 2620053
• Product Code: FMI
• UDI-Device Identifier: 00041260007781
• UDI-Public: 00041260007781
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2023
• Report Date (Section F): 03/10/2023

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 3540KRO
• Device Lot Number: 22A9003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2023
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/10/2023
• Device Age: 13 MO
• Event Location: Home
• Date Report to Manufacturer: 02/15/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2023
• 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: 64 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Date Report Sent to FDA: 03/10/2023