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

Model Number	AN 3850AH
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
Owen mumford usa inc's distributor received a letter from one of their patients stating she had two boxes of their private labeled pen needles, unifine pentips plus and a needle from each box broke off in her abdomen.She reported in the letter to them that she was able to remove one herself, but had to go get an x-ray to see if the other could be found, but it could not be located.
Additional Manufacturer Narrative
Owen mumford usa inc customer service was able to contact the patient, (b)(6).She communicated that she is ok, but just wanted us to know she had two needles, on separate occasion, break off in her abdoment and she had never had that happen before.

• Brand Name: CAREONE 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: 18373705
• Report Number: 8021764-2023-00007
• Device Sequence Number: 7766672
• Product Code: FMI
• UDI-Device Identifier: 00041520035363
• UDI-Public: 00041520035363
• 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): 01/05/2024

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 3850AH
• Device Lot Number: 22P8001.C484
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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 Sex: Female