MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT); HYPODERMIC SINGLE LUMEN NEEDLE

Model Number 320550

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 12/05/2022

Event Type  malfunction  

Event Description

It was reported while using bd nano¿ 2nd gen pen needles 32g x 4mm (100 count) there were missing labels that caused a sterility breach.This occurred 20 times.There was no report of patient impact.The following information was provided by the initial reporter: 20 pen needles missing tear drop labels fromthis box.

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.Address information was not able to be obtained, therefore, nj was used as a place holder.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd nano¿ 2nd gen pen needles 32g x 4mm (100 count) there were missing labels that caused a sterility breach.This occurred 20 times.There was no report of patient impact.The following information was provided by the initial reporter: 20 pen needles missing tear drop labels fromthis box.

Manufacturer Narrative

The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 03jan2023.H.6 investigation summary: samples were received and an investigation was performed.This is the first complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Embecta was not able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

• Brand Name: BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)
• 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: 16046024
• MDR Text Key: 308290090
• Report Number: 9616656-2022-01412
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182320
• 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
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 320550
• Device Catalogue Number: 320550
• Device Lot Number: 2060472
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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