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 Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2020

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.(b)(4).

Event Description

It was reported that during use with a bd nano¿ 2nd gen pen needle insulin was unable to be injected.The following information was provided by the initial reporter: (1 of 2 complaints) it was reported that the needle was clogged.

Manufacturer Narrative

Investigation summary: no samples (including photos) were returned as of 19 october 2020 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.

Event Description

It was reported that during use with a bd nano¿ 2nd gen pen needle insulin was unable to be injected.The following information was provided by the initial reporter: (1 of 2 complaints).It was reported that the needle was clogged.

• 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
• MDR Report Key: 10611068
• MDR Text Key: 209585647
• Report Number: 9616656-2020-00985
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903205509
• UDI-Public: 00382903205509
• Combination Product (y/n): N
• PMA/PMN Number: K182320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

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: Lay User/Patient
• Device Model Number: 320550
• Device Catalogue Number: 320550
• Device Lot Number: 9281256
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 09/10/2020
• Supplement Dates FDA Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other