MAUDE Adverse Event Report: BECTON DICKSON BD; ECLIPSE VACUTAINER NEEDLE

Lot Number 4176703

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 11/06/2014

Event Type  malfunction  

Event Description

Becton dickson (bd) eclipse vacutainer needle lot # 4176703 expiration 07/2019 had the safety device snap off during use by the phlebotomist.

• Brand Name: BD
• Type of Device: ECLIPSE VACUTAINER NEEDLE
• Manufacturer (Section D): BECTON DICKSON
• MDR Report Key: 4305587
• MDR Text Key: 5057268
• Report Number: MW5039403
• Device Sequence Number: 1
• Product Code: JKA
• 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: 11/14/2014

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: 07/01/2019
• Device Lot Number: 4176703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2014
• Patient Sequence Number: 1