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

Model Number 320550

Device Problem Misconnection (1399)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd nano¿ 2nd gen pen needle was not working.The following information was provided by the initial reporter: consumer stated she is not getting her complete dosage.

Manufacturer Narrative

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.Embecta was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.H3 other text : see h10.

Event Description

It was reported that the bd nano¿ 2nd gen pen needle was not working.The following information was provided by the initial reporter: consumer stated she is not getting her complete dosage.

• Brand Name: BD NANO¿ 2ND GEN PEN NEEDLE
• Type of Device: 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: 15946532
• MDR Text Key: 306752811
• Report Number: 9616656-2022-01334
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 50382903205504
• UDI-Public: 00382903205509
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 320550
• Device Catalogue Number: 320550
• Device Lot Number: 2026081
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1