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

Model Number	8975
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd nano¿ ultra-fine¿ pen needles the medication could not be delivered.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported needle clog during injection, stated that there is no insulin flow.
Additional Manufacturer Narrative
H6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.
Event or Problem Description
It was reported while using bd nano¿ ultra-fine¿ pen needles the medication could not be delivered.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported needle clog during injection, stated that there is no insulin flow.

• Brand Name: BD NANO¿ ULTRA-FINE¿ PEN NEEDLES
• 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: 16040885
• Report Number: 9616656-2022-01410
• Device Sequence Number: 15012163
• Product Code: FMI
• UDI-Device Identifier: 10885403897511
• UDI-Public: (01)10885403897511
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K213478
• 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): 01/10/2023

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: Other
• Device Model Number: 8975
• Device Catalogue Number: 320883
• Device Lot Number: 2005391
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 12/23/2022
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown