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

• 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
• Manufacturer (Section G): Owen Mumford Limited; primsdown industrial estate; worcester rd.; chipping norton, oxfordshire OX7 5 XP; UK OX7 5XP
• Manufacturer Contact: patty haney ; 1755 west oak commons ct.; marietta, GA 30062 ; +1(770)977-2226
• MDR Report Key: 50889508
• Report Number: 8021764-2026-00011
• Device Sequence Number: 13431881
• Product Code: FMI
• UDI-Device Identifier: 00384703840010
• UDI-Public: 00384703840010
• 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
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• 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
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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