MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS NEEDLE SFTYGLD 27X5/8 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305921
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that needle sftygld 27x5/8 rb safety mechanism broke.This was discovered after use.The following information was provided by the initial reporter: material no: 305921 batch no: 9170943.It was reported that when trying to activate the safety function, the plastic safety broke off leaving the needle exposed.Event description per email states: i wanted to report a broken safety on a needle that was broken and posed a safety risk to one of our caregivers during an injection at our hospital on 1/24.This was escalated to our senior leadership.A nurse was giving a hep b vaccine today to a baby and after giving the injection and trying to activate the safety function the plastic safety broke off leaving the needle exposed.The item number is a bg safetyglide needle 27 g x 5/8 in.I took pictures of the packaging and of the needle with the plastic safety broken off.It should have remained intact to cover the needle to prevent needle sticks.We put the needle in the sharps since it had been injected into an infant just a few minutes before.This did not result in a needle stick in an employee but had the potential to be a safety risk.
Event or Problem Description
It was reported that needle sftygld 27x5/8 rb safety mechanism broke.This was discovered after use.The following information was provided by the initial reporter: material no: 305921 batch no: 9170943 it was reported that when trying to activate the safety function, the plastic safety broke off leaving the needle exposed.Event description per email states: i wanted to report a broken safety on a needle that was broken and posed a safety risk to one of our caregivers during an injection at our hospital on 1/24.This was escalated to our senior leadership.A nurse was giving a hep b vaccine today to a baby and after giving the injection and trying to activate the safety function the plastic safety broke off leaving the needle exposed.The item number is a bg safetyglide needle 27 g x 5/8 in.I took pictures of the packaging and of the needle with the plastic safety broken off.It should have remained intact to cover the needle to prevent needle sticks.We put the needle in the sharps since it had been injected into an infant just a few minutes before.This did not result in a needle stick in an employee but had the potential to be a safety risk.
Additional Manufacturer Narrative
H.6.Investigation summary two photos were received and evaluated.One photo depicted a single package from the top web view, confirming batch #9170943 (p/n 305921).One photo depicted a safetyglide needle attached to a small nonbd syringe with a luer-lok adapter, all held by gloved hands.The safety shield was observed broken at the hinge with the tip portion held separate from the rest of the needle in one hand.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Possible root cause is associated with the safetyglide assembly line.The plastic hub is placed under the cannulator then the needle is positioned and assembled to the plastic hub adding the epoxy to fix it; after that, a plastic safety mechanism is assembled, then at the end the plastic shield is assembled to the part.In this case, the safety mechanism was not properly assembled.No corrective actions are necessary based on the defective rate identified.Batch 9170943 is considered in compliance with our product specification requirements.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: NEEDLE SFTYGLD 27X5/8 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9717817
• Report Number: 1213809-2020-00107
• Device Sequence Number: 16876274
• Product Code: FMI
• UDI-Device Identifier: 30382903059219
• UDI-Public: 30382903059219
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/30/2024
• Device Model Number: 305921
• Device Catalogue Number: 305921
• Device Lot Number: 9170943
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other