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

Model Number	AN 3540
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Anxiety (2328)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number customer reported was not a full lot number and therefore batch records could not be reviewed.The customer still has not returned the medical questionnaire requested, and has been followed up multiple times.Our us division is the importer and has also reported this event - report number is 1058602-2020-00006.
Event or Problem Description
Customer called our us division to let them know that pen needle broke off in her stomach.She stated she went to the doctor and had an x-ray taken and nothing showed as a foreign object in her skin, but there was still some irritation there.Patient stated she did not save the needle, nor the box with the product information.She did not disclose the date of the event.

• 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: 10838662
• Report Number: 8021764-2020-00006
• Device Sequence Number: 19740514
• Product Code: FMI
• UDI-Device Identifier: 00384703540019
• UDI-Public: 00384703540019
• 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: consumer,distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2020

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 Model Number: AN 3540
• Device Catalogue Number: AN3540
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2020
• 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