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

Model Number	4938494
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A batch file and retained sample review was performed and did not highlight any anomalies that could account for this event.The devices in question were returned for examination and upon inspection by mps team at owen mumford ltd, one pentip hub had the needle bent back and one pentip hub had the needle snapped off.The samples were then placed under high magnification for further assessment.The needle tube inside the hub, has been bent at an angle and squashed which indicates material resistance from force.From the finding observed in figure 1, the needle appears to have been broken off under force after moulding, indicating no issues with the assembly / manufacture of the device.Figure 2 shows the needle bent away from its original vertical positioning.It also has a second bend towards the tip of the needle indicating a use of force upon the needle causing it to bend.This damage to the needle indicates the needle has been used.The needle shield could not have been placed over the needle if the needle was damaged.This could be caused by placing the hub at an angle when inserting the needle into the disposal chamber.The needle is also discolored which indicates that insulin has oxidized on the needle, which also indicates the pentip was used.Full report is attached.
Event or Problem Description
Patient called the us office (importer) on (b)(6) 2022 to report that a pen needle got stuck in her leg, but that she was able to remove it herself.She also complained that another needle was already bent and was not able to give herself an injection with it.

• 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: patty haney ; 1755 west oak commons ct.; marietta, GA 30062 ; 7709772226
• MDR Report Key: 16253110
• Report Number: 8021764-2023-00001
• Device Sequence Number: 14802523
• Product Code: FMI
• UDI-Device Identifier: 00096295125597
• UDI-Public: 00096295125597
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2023

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 Model Number: 4938494
• Device Catalogue Number: 4938494
• Device Lot Number: 22EA004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 78 KG