MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA-FINE¿ MICRO PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	72213N
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd ultra-fine¿ micro pen needle was unable to deliver insulin.The following information was provided by the initial reporter: consumer reported finding needle would not allow insulin through.
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: customer returned a total of 32 used and 8 unused 6mm, 32 gauge pen needles from lot 1320842.30 of the pen needles were visually inspected and no immediately observable defects were found.The pen needles were then attached to a test pen.Saline was pushed through the system and out the distal tips of the pen needles with no issues.No clog, attachment issues, or shortened cannulas observed in any of the tested samples.All samples were undamaged and functioned as intended.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.Based on the samples received, embecta was unable to confirm the customer¿s indicated failure of needle clogs.Root cause cannot be determined at this time as the issue is unconfirmed.
Event or Problem Description
It was reported that the bd ultra-fine¿ micro pen needle was unable to deliver insulin.The following information was provided by the initial reporter: consumer reported finding needle would not allow insulin through.

• Brand Name: BD ULTRA-FINE¿ MICRO PEN NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer (Section G): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15802651
• Report Number: 9616656-2022-01247
• Device Sequence Number: 14858634
• Product Code: FMI
• UDI-Device Identifier: 07613203010078
• UDI-Public: 07613203010078
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K162516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 72213N
• Device Catalogue Number: 320749
• Device Lot Number: 1320842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2022
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown