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

Model Number	AN 3840
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Distress (2329); Discomfort (2330)
Date of Event	08/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: the medicines listed were: neurontin 300mg 3x daily, morphine 60mg 2x daily, xanax 1/2mg daily, zyrtec, aspirin 81mg, carvedilol 2mg 2x daily, lisinopril 10mg daily.
Event or Problem Description
Customer stated she has had multiple needles break off in her skin during injecting insulin with levemir flexpen, specifically two in the last week.She did not have the hubs for the needles that had broken, she does have some unused pen needles left.She was instructed to make an appointment with her doctor to discuss changing needle lengths, as well as to evaluate the needles that may be in her skin.Upon receipt of the medical questionnaire she informed us she has discussed the issue with her primary care physician on (b)(6) 2018 and that as of (b)(6) 2018, she or her primary care physician has not seen any visible signs of any problems.No further action was taken.
Additional Manufacturer Narrative
Complaint investigation report and outside laboratory report.

• Brand Name: UNIFINE PENTIPS PLUS
• Common Device Name: PEN NEEDLES
• Manufacturer (Section D): OWEN MUMFORD LIMITED; brook hill; woodstock, oxfordshire OX20 1TU; UK OX20 1TU
• MDR Report Key: 8388167
• Report Number: 8021764-2018-00007
• Device Sequence Number: 13899211
• Product Code: FMI
• UDI-Device Identifier: 00761059840190
• UDI-Public: 00761059840190
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2019

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: Lay User/Patient
• Device Expiration Date: 03/28/2023
• Device Model Number: AN 3840
• Device Lot Number: 18HA001.U572
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 03/07/2019
• 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: 66 YR
• Patient Weight: 107