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

Model Number	AN 3530
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Anxiety (2328)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Patient called in to our us office to report that while giving herself her insulin shot, when she pulled the pen out the needle was missing.
Additional Manufacturer Narrative
No product was returned for assessment.The third-party supplier batch file review did not highlight any anomalies that could account for this issue.The retained samples were visually inspected, and breakage tested with no issues found.The batch was manufactured on dec 2019 and as stated by the third-party manufacturer: "it is in their experience that the alleged breakage could have occurred by user error in the following scenarios: angle of the needle in respect to the skin.Overload force applied during injection.Reuse of the device.Patient moving during injection.The medical questionnaire was completed by the user and no needle was found and no medical care/ intervention was required.No further action can be taken at this time.

• Brand Name: UNIFINE PENTIPS
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): OWEN MUMFORD LIMITED; brook hill; woodstock, oxfordshire OX20 1TU; UK OX20 1TU
• MDR Report Key: 11197515
• Report Number: 8021764-2021-00001
• Device Sequence Number: 19002184
• Product Code: FMI
• UDI-Device Identifier: 00384703530010
• UDI-Public: 00384703530010
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2021

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: 10/01/2024
• Device Model Number: AN 3530
• Device Catalogue Number: AN3530
• Device Lot Number: 1910737
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 03/05/2021
• 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: 45 YR
• Patient Weight: 139