Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON, DICKINSON AND COMPANY BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION Back to Search Results
Model Number 367344
Device Problem Defective Device (2588)
Patient Problem Exposure to Body Fluids (1745)
Event Date 12/01/2017
Event Type  malfunction  
Event Description
New bd vacutainer push button blood collection set is defective.When the push button is pushed, blood splatters on staff.Two event reports were completed before we pulled them from use.I have the box of defective products and have instructed staff to use something else for phlebotomy.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET
Type of Device
TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
1 becton drive
franklin lakes NJ 07417 1885
MDR Report Key7577545
MDR Text Key110346332
Report Number7577545
Device Sequence Number1
Product Code JKA
UDI-Device Identifier00382903673445
UDI-Public(01)00382903673445
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/05/2017,05/31/2018
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 Nurse
Device Expiration Date07/31/2019
Device Model Number367344
Device Catalogue Number367344
Device Lot Number2019-07-31
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/05/2017
Device Age3 MO
Event Location Hospital
Date Report to Manufacturer12/05/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO - FAULTY NEW PRODUCT
-
-