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

Model Number 320550

Device Problem Failure to Prime (1492)

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

Event Date 12/07/2022

Event Type  malfunction  

Event Description

It was reported that 2 bd nano¿ 2nd gen pen needles were unable to prime.The following information was provided by the initial reporter: consumer stated no insulin flow when priming.

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.

Manufacturer Narrative

Device available for eval yes, returned to manufacturer on: 03-jan-2023.: investigation summary: customer returned one pen needle.It was reported by the consumer that needle was bent prior to injection and needle clogged during priming.The needle was visually inspected and was found bended on the non-patient end side.Based on the damage present the needle bending may have occurred accidently, while the user was preparing the pen needle for use.Potentially if the pen was not aligned with the canula.As a result of the bend needle there will be no flow through the needle which refers to the customer complaint of the needle clog during priming.Refer to the attached photos.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 able to confirm the customer¿s indicated failure of needle clog.The root cause of the needle appears to be accidental damage from stresses caused by the user during routine use.This would have also given the impression that the needle was clogged since insulin would be unable to pass through the cannula.

Event Description

It was reported that 2 bd nano¿ 2nd gen pen needles were unable to prime.The following information was provided by the initial reporter: consumer stated no insulin flow when priming.

• 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: 16075085
• MDR Text Key: 308074788
• Report Number: 9616656-2022-01429
• Device Sequence Number: 1
• Product Code: FMI
• 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: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• 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: 2005376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2022
• 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