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'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 abdoment.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 ms (b)(6).She communicted that she had two needles on separate occasions break off in her abdomen and that this had never happened before.The x-ray machine at the hospital did not detect a broken needle in her skin, possibly because it was too small, but she is ok and just wanted to let us know what had happened.No other information was given.

• 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
• MDR Report Key: 18373740
• Report Number: 1058602-2023-00007
• Device Sequence Number: 7617407
• Product Code: FMI
• UDI-Device Identifier: 00041520035363
• UDI-Public: 00041520035363
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/21/2023
• Report Date (Section F): 12/21/2023

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 3850AH
• Device Lot Number: 22P8001.C484
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/27/2023
• Device Age: 16 MO
• Event Location: Home
• Date Report to Manufacturer: 11/30/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2023
• 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 Sex: Female
• Date Report Sent to FDA: 12/21/2023