MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD NANO¿ 2ND GEN PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	320122
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.The customer's address is unknown.(b)(6) has been used as a default.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd nano¿ 2nd gen pen needle was unable to deliver insulin.The following was received from the initial reporter: voice message caller.Using bd pen needles nothing coming out of needle - finding the npe to be missing.
Additional Manufacturer Narrative
The following fields have been updated due to a correction: after further evaluation of the complaint, it has been determined that the previously submitted report 9235517was sent in error and confirmed a concomitant effect of the initial failure.Complaint captured under report (b)(4) mfr#9616656-2023-01218.Mfr#: 9616656-2023-01239 is void as a result.
Event or Problem Description
It was reported that the bd nano¿ 2nd gen pen needle was unable to deliver insulin.The following was received from the initial reporter: voice message caller.Using bd pen needles nothing coming out of needle - finding the npe to be missing.
Event or Problem Description
It was reported that the bd nano¿ 2nd gen pen needle was unable to deliver insulin.The following was received from the initial reporter: voice message caller.Using bd pen needles nothing coming out of needle - finding the npe to be missing.
Additional Manufacturer Narrative
The following fields have been updated due to a correction: correction submitted for the reported report id 9235517 previously submitted sent in error is incorrect, the correct report sent in error is 9385451.

• Brand Name: BD NANO¿ 2ND GEN 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 18325362
• Report Number: 9616656-2023-01239
• Device Sequence Number: 7358485
• Product Code: FMI
• UDI-Device Identifier: 10885403928659
• UDI-Public: (01)10885403928659
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2024

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 Catalogue Number: 320122
• Device Lot Number: 3101673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 11/10/2023; 01/11/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 12/20/2023; 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2023
• 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