MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA FINE¿ PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 320119

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Blood Loss (2597)

Event Date 07/25/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: a complaint history check was performed and this is the 1st related complaint for needle point dull, harm & foreign matter on lot # 6236665.Investigation summary: customer returned (5) 5mm, 31g pen needles (2 open, 3 sealed) from lot # 6236665.Customer states that the needles are dull, there is bleeding, and there is needle damage.All returned pen needles were examined and no foreign matter was observed on any of the samples.All samples were also tested for point geometry, lube, and cannula od.The following was observed (specs: outer diameter for 31g: 0.0100¿-0.0105¿): (b)(6).All observations fall within specifications.No defects were observed on any of the returned samples.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 per the applicable operations and met qc specifications.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed.

Event Description

It was reported that foreign matter occurred during use with a bd ultra fine¿ pen needle.The following information was provided by the initial reporter, "from phone call on (b)(6) 2019 08:01:04: called to describe what it is he means by protrusion.He stated it looks like the metal when cut if angle to make sharp.Little piece of metal hangs out.It has been happening for several weeks.Harder than usual to prick himself.He saw needle had bubble and he wiped off the fluid, it was indeed frawn of the metal.He does not do priming.He used to do the priming in the past.He visually tests the needle to see if it is straight.He re uses the needle several times, about 4 to 5 times.He is aware of not to re use the needles.He does rotate the skin site for injection and firmly attaches the pen needle to the pen.Consumer reported it was difficulty piercing thru the skin during injection it was dull.He was injecting on his leg.He bled more this time.When i verified if he had bled in the past he said no.He cleaned the blood with a kleenex.When he looked at the tip with the magnifying glass, he noticed protrusion on both end of the tip.This has never happened before, he has been using the mini pen needle for long time.Incident date- (b)(6) 2019; occurence- 5.".

• Brand Name: BD ULTRA FINE¿ 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8898618
• MDR Text Key: 154786488
• Report Number: 9616656-2019-00758
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903201198
• UDI-Public: 00382903201198
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 320119
• Device Lot Number: 6236665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2016
• 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
• Patient Outcome(s): Other