MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET; BUTTERFLY NEEDLE

Catalog Number 368559

Device Problems Leak/Splash (1354); Device Damaged Prior to Use (2284); Cut In Material (2454); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Blood Loss (2597)

Event Date 04/18/2018

Event Type  Injury  

Event Description

Becton, dickinson (bd) push button blood collection set (butterfly needle), after opening the butterfly needle package and inserting needle into patient's vein, staff are complaining about patient blood spilling on to their skin and clothing because tubing of butterfly needle is cut causing blood to leak from the tubing before reaching the vacutainer collection tube.I have documentation that i have been contacting bd regarding the tubing of their butterfly needle tubing getting sliced during assembly and getting packaged and distributed to health care facilities.I have been contacting bd regarding this defect that is occurring during assembly since 2014.The defective products are still being delivered to health care facilities today.Dates of use: (b)(6) 2014 - (b)(6) 2018.

• Brand Name: BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BUTTERFLY NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; franklin lakes NJ 07417
• MDR Report Key: 7521658
• MDR Text Key: 108661550
• Report Number: MW5077272
• Device Sequence Number: 1
• Product Code: JKA
• 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: 05/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 368559
• Device Lot Number: 8003964
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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): Life Threatening