MAUDE Adverse Event Report: BD VACUTAINER; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number 368607

Device Problem Protective Measures Problem (3015)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/23/2019

Event Type  malfunction  

Event Description

A phlebotomist was going to use a bd vacutainer needle and when removing the cap, the safety came off the device, making it an unsafe needle to use.Needle was discarded.

• Brand Name: VACUTAINER
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BD; 5859 farinon drive; san antonio TX 78249
• MDR Report Key: 9535171
• MDR Text Key: 173190022
• Report Number: 9535171
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 368607
• Device Lot Number: 9177807
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1