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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OWEN MUMFORD LIMITED UNIFINE PENTIP; PEN NEEDLE
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OWEN MUMFORD LIMITED UNIFINE PENTIP; PEN NEEDLE Back to Search Results
Model Number AN 3540AC
Medical Device Problem Code Separation Problem (4043)
Health Effect - Clinical Code Foreign Body In Patient (2687)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Could not file the mdr until today as my account was just approved today, (b)(6) 2025.
 
Event or Problem Description
Customer stated she used 3-4 pentip needles and they would get stuck to her skin when trying to remove needle from the stomach.One of the needles broke off in her stomach.She went to the hospital to get it removed.
 
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Brand Name
UNIFINE PENTIP
Common Device Name
PEN NEEDLE
Manufacturer (Section D)
OWEN MUMFORD LIMITED
brook hill
woodstock, oxfordshire OX20 1TU
UK  OX20 1TU
MDR Report Key22361195
Report Number1058602-2025-00004
Device Sequence Number12916983
Product Code FMI
UDI-Device Identifier00761059354000
UDI-Public00761059354000
Combination Product (Y/N)N
Initial Reporter CountryCA
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/30/2025
Report Date (Section F) 06/30/2025
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
Operator of Device Lay User/Patient
Device Model NumberAN 3540AC
Device Lot Number24R9001
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date05/27/2025
Device Age11 MO
Event Location Home
Date Report to Manufacturer05/28/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/30/2025
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age55 YR
Patient SexFemale
Patient Weight122 KG
Date Report Sent to FDA06/30/2025
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