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

Model Number	AN 3540AC
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer stated from email on nov 27, 2024: i had a defective pen needle today requiring a visit to a hospital to get my insulin shot.This is the second time, so i am very concerned.What can you do about this ongoing problem as this the second time it happened to me.Needle part that goes into insulin tube was not there and insulin could not be injected.

• Brand Name: UNIFINE PENTIP
• 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: jeanetta mckinley ; 1755 west oak commons ct.; marietta, GA 30062 ; 7709772226
• MDR Report Key: 21379491
• Report Number: 8021764-2025-00001
• Device Sequence Number: 15571104
• Product Code: FMI
• UDI-Device Identifier: 00761059354000
• UDI-Public: 00761059354000
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2025

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
• Device Model Number: AN 3540AC
• Device Lot Number: 2403736.E568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Male