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

Model Number	AN 3850
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient called in to report that a needle broke off in her abdomen while giving herself her insulin shot.She reported she pulled it out herself.

• 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
• MDR Report Key: 13529265
• Report Number: 1058602-2022-00001
• Device Sequence Number: 5325276
• Product Code: FMI
• UDI-Device Identifier: 00384703850019
• UDI-Public: 00384703850019
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/14/2022
• Report Date (Section F): 02/14/2022

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: 04/28/2026
• Device Model Number: AN 3850
• Device Lot Number: 21K8002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/02/2022
• Device Age: 9 MO
• Event Location: Home
• Date Report to Manufacturer: 02/04/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2022
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Date Report Sent to FDA: 02/14/2022