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

Model Number	AN 3590HEB
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Customer called us office to make a complaint that one of her needles broke off in her stomach and it was the first time she tired to use it.She also said a second needle broke off before she could get it on her pen.Customer reported that she intended to make a doctor appointment.

• Brand Name: UNIFINE 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 USA INC; 1755 west oak commons ct.; marietta GA 30062
• Manufacturer Contact: darren mansell ; brook hill; woodstock, oxfordshire OX20 -1TU ; UK OX20 1TU
• MDR Report Key: 15243259
• Report Number: 8021764-2022-00004
• Device Sequence Number: 6293064
• Product Code: FMI
• UDI-Device Identifier: 00041220814541
• UDI-Public: 00041220814541
• 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): 08/17/2022

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: Lay User/Patient
• Device Expiration Date: 05/01/2024
• Device Model Number: AN 3590HEB
• Device Catalogue Number: AN 3590HEB
• Device Lot Number: 1905755
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2019
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 93 KG