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

Model Number	AN 3850
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	Distress (2329); Discomfort (2330); Foreign Body In Patient (2687)
Date of Event	04/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Original mdr filed on webtrader on (b)(6) 2018.This initial report is being submitted per fda request, via email stating they have no record of this report.The information included is taken directly from the original report filed, which is also included as an attachment, along with teh webtrader acknowledgments in the file."on guidance document with questions about the event, patient reported he only uses his needles for one injection and then changes his needles.We will not be able to evaluate the broken hub as reported he disposed of it at the time of the injection.It is industry knowledge that diabetics reuse their pen needles more than one time which causes stress on the needle and can lead to breaking off.".
Event or Problem Description
Patient's doctor called on (b)(6) 2018 stating the patient came into his office a couple of days earlier with a pen needle that had broken off into his stomach during an injection of insulin.The doctor was instructed to have the patient call directly to obtain the medical information, as they could not release it.Patient called and reported the doctor sent him to the hospital for x-rays.Teh doctor decided to watch the affected area for reness, bruising and possible movement of the needle.The patient was told it would have to be surgically removed.The pen needle hub the needle broke off had been disposed and not available to send for investigation.

• Brand Name: UNIFINE PENTIPS PLUS
• 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: patricia cronan ; 1755 west oak commons ct.; marietta, GA 30062 ; 7709772226
• MDR Report Key: 7820115
• Report Number: 8021764-2018-00001
• Device Sequence Number: 8528403
• Product Code: FMI
• UDI-Device Identifier: 00384703850019
• UDI-Public: 00384703850019
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2023

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 Expiration Date: 10/28/2022
• Device Model Number: AN 3850
• Device Lot Number: 17W8001.T861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 08/27/2018
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2017
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 91 KG