MAUDE Adverse Event Report: BECTON DICKINSON & CO (BD) BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE 22GX1-1/4; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 368608

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Needle Stick/Puncture (2462); Blood Loss (2597)

Event Date 10/03/2018

Event Type  malfunction  

Event Description

When gathering needle to start our company's sharps assessment survey i held the 2 vacutainers and felt a poking sensation on my left middle finger.While looking at my hand, i saw that the 22gx1-1/4" bd vacutainer eclipse blood collection needle was protruding for the plastic sheath.The needle was clean and unopened but did cause little bleeding.Dates of use: (b)(6) 2017 to (b)(6) 2018.Reason for use: safety assessment; encounter for lab blood draw.

• Brand Name: BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE 22GX1-1/4
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON & CO (BD)
• MDR Report Key: 7979060
• MDR Text Key: 124500531
• Report Number: MW5080652
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/04/2018

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: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 368608
• Device Catalogue Number: 368608
• Device Lot Number: 7041650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Weight: 83