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

Model Number	AN3550
Medical Device Problem Codes	Nonstandard Device (1420); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
When a new needle was opened, the needle was exposed outsideof the needle cap and it pricked the user's (nurse) finger.

• Brand Name: UNIFINE PENTIPS
• 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: patty haney ; 1755 west oak commons ct.; marietta, GA 30062 ; 7709772226
• MDR Report Key: 20046785
• Report Number: 8021764-2024-00005
• Device Sequence Number: 15464849
• Product Code: FMI
• UDI-Device Identifier: 00384703550018
• UDI-Public: 00384703550018
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2024

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: Health Professional
• Device Model Number: AN3550
• Device Lot Number: 23V7001 (09406)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 26 YR
• Patient Sex: Female