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

Model Number	AN 3830
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Discomfort (2330); Needle Stick/Puncture (2462)
Date of Event	09/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unifine pentips plus has warnings and precautions listed on the device; this device is "not for clinical use".The device in question was never returned for evaluation.The complaint final report is attached.
Event or Problem Description
A medication technician with rest assured living center placed the safety cap onto a pen needle to remove the needle from a patient's insulin pen and the needle went through the cap, and stabbed the technician.Technician then made an appointment at (b)(6) health care that same day ((b)(6) 2019) to be evaluated for cross infections that could have occurred.The technician was placed on antiviral medications with follow-ups in 2 weeks, 1 month, 6 months and a year.

• Brand Name: UNIFINE PENTIPS PLUS
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): OWEN MUMFORD LIMITED; brook hill; woodstock, OX20 1TU; UK OX20 1TU
• MDR Report Key: 9182859
• Report Number: 8021764-2019-00014
• Device Sequence Number: 2774209
• Product Code: FMI
• UDI-Device Identifier: 00384703830011
• UDI-Public: 00384703830011
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/11/2019
• Report Date (Section F): 10/11/2019

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 Expiration Date: 06/28/2023
• Device Model Number: AN 3830
• Device Lot Number: 18P4001.V876
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/10/2019
• Device Age: 15 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/11/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 10/11/2019
• 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 Age: 32 YR
• Patient Weight: 82
• Date Report Sent to FDA: 10/11/2019