MAUDE Adverse Event Report: Owen Mumford Limited Unifine Pentips Plus; pen needle

Model Number	AN 3840
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer stated her pentip needles are bending when doing her injections and on one of them when she removed the neede from the injection site, the needle was not there.It appeared to be broken off, but she is unsure if the needle is still in her skin or not.After following up again, she indicated she did not go the dr and she is fine.

• Brand Name: Unifine Pentips Plus
• Common Device Name: pen needle
• Manufacturer (Section D): Owen Mumford Limited; primsdown industrial estate; worcester rd.; chipping norton, oxfordshire OX7 5 XP; UK OX7 5XP
• MDR Report Key: 50889509
• Report Number: 1058602-2026-00011
• Device Sequence Number: 21502720
• Product Code: FMI
• UDI-Device Identifier: 00384703840010
• UDI-Public: 00384703840010
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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 3840
• Device Lot Number: 007578
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 13 MO
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2026
• 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: Female
• Date Report Sent to FDA: 09/24/2026