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

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	Serious Injury
Event or Problem Description
Customer stated from email on (b)(6) 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 PENTIPS
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): OWEN MUMFORD LIMITED; brook hill; woodstock, oxfordshire OX20 1TU; UK OX20 1TU
• MDR Report Key: 21379286
• Report Number: 1058602-2025-00001
• Device Sequence Number: 18274213
• Product Code: FMI
• UDI-Device Identifier: 00761059354000
• UDI-Public: 00761059354000
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2025
• Report Date (Section F): 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2025
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/14/2025
• Event Location: Home
• Date Report to Manufacturer: 01/14/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2025
• 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 Sex: Male
• Date Report Sent to FDA: 02/13/2025