MAUDE Adverse Event Report: OWEN MUMFORD LIMITED UNFINE PENTIPS; 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
Custoomer stated to us oiffice that 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 teh pen needle hub.She has not gone to the doctor and reported that she watched the site and did not go to the er.

• Brand Name: UNFINE PENTIPS
• Common Device Name: PEN NEEDLE
• 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 haney ; 1755 west oak commons ct.; marietta, GA 30062 ; 7709772226
• MDR Report Key: 16526435
• Report Number: 8021764-2023-00002
• Device Sequence Number: 2620056
• Product Code: FMI
• UDI-Device Identifier: 00041260007781
• UDI-Public: 00041260007781
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K152339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 91 KG