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 Misconnection (1399)

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

Event Date 10/10/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.Medical device lot #: 1350513 was reported, however, this is not a lot # manufactured for the reported catalog #.Medical device expiration date: unknown.Device manufacture date: unknown.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) the needles were difficult to use.This occurred 6 times.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported -had a box of them and at least six of them do not work.She tests them first and nothing happened on six of them.

Event Description

It was reported while using bd nano¿ 2nd gen pen needles 32g x 4mm (100 count) the needles were difficult to use.This occurred 6 times.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported -had a box of them and at least six of them do not work.She tests them first and nothing happened on six of them.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 09-nov-2022.H6: investigation summary customer returned a total of 11 unused 4mm, 32 gauge nano pen needles from lot 1350513.There were no immediately visible defects to the pen needles.The pen needles were attached to a test pen.Saline was pushed through the system and out the distal tip of the pen needles without issue.The pen needles were undamaged and functioned as intended.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 unable to confirm the customer¿s indicated failure of the pen needles not working.Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h10.

• 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: 15718356
• MDR Text Key: 307479631
• Report Number: 9616656-2022-01185
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903205509
• UDI-Public: 00382903205509
• 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,Followup
• Report Date: 01/09/2023

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
• Device Operator: Other
• Device Model Number: 320550
• Device Catalogue Number: 320550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 10/10/2022
• Initial Date FDA Received: 11/02/2022
• Supplement Dates Manufacturer Received: 01/09/2023
• Supplement Dates FDA Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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