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

Model Number	AN 3450
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer's boyfriend called in to om inc to report the day after she gave herself an injection.He communicated that when she went to pull it out the needle broke off in her skin.She went to the er and they were able to remove it.She does not have the pen needle hub or the pen needle they removed to send back.
Additional Manufacturer Narrative
A medical questionnaire was sent to consumer by the us division, om inc to get more information.It was never returned.Om inc followed up three times with the consumer to try to obtain the completed medical questionnaire for more information.On each occasion the patient/ consumer agreed to send it back, however, it was never returned.

• Brand Name: PENTIPS
• 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: 17406370
• Report Number: 8021764-2023-00005
• Device Sequence Number: 5900407
• Product Code: FMI
• UDI-Device Identifier: 00384703450011
• UDI-Public: 00384703450011
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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: AN 3450
• Device Lot Number: 2112738
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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: 56 YR
• Patient Sex: Female