MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ HYPODERMIC NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305762
Medical Device Problem Codes	Leak/Splash (1354); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	06/25/2019
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 bd eclipse¿ hypodermic needle had a safety mechanism failure and separated from the syringe.This caused a needle stick injury to the caregiver.This occurred during use.No date/time or patient information was given.The following information was provided by the initial reporter: material no.305762, batch no.8236049.It was reported there was a needle stick.After administering the vaccine in a patient, the caregiver was engaging the safety lock of the needle on a prefilled hepatitis a vaccine, when the needle came off of the syringe and poked the caregiver in her finger.She immediately washed off the cut and we reported it to employee health who advised patient go to the ed for bloodwork.
Event or Problem Description
It was reported that bd eclipse¿ hypodermic needle had a safety mechanism failure and separated from the syringe.This caused a needle stick injury to the caregiver.This occurred during use.No date/time or patient information was given.The following information was provided by the initial reporter: material no.305762; batch no.8236049.It was reported there was a needle stick.After administering the vaccine in a patient, the caregiver was engaging the safety lock of the needle on a prefilled hepatitis a vaccine, when the needle came off of the syringe and poked the caregiver in her finger.She immediately washed off the cut and we reported it to employee health who advised patient go to the ed for bloodwork.
Additional Manufacturer Narrative
H.6.Investigation: a device history record review was performed and showed no non-conformances associated with this issue during the production of this batch.Since no samples or photos displaying the condition reported are available for examination, we were unable to fully investigate this incident.A root cause could not be determined and complaint is unconfirmed.

• Brand Name: BD ECLIPSE¿ HYPODERMIC NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8800613
• Report Number: 8041187-2019-00553
• Device Sequence Number: 2693323
• Product Code: FMI
• UDI-Device Identifier: 30382903057628
• UDI-Public: 30382903057628
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• 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): 08/20/2019

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: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 305762
• Device Lot Number: 8236049
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/20/2019
• 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: Required Intervention