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 & CO., (BD) BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE
  • 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 & CO., (BD) BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 367981
Medical Device Problem Code Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/20/2015
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.A review of the manufacturing records was completed for the incident lot and no issues were identified.
 
Event or Problem Description
It was reported that the bd vacutainer® sst¿ blood collection tubes had poor barrier sepration caused no serious injury medical intervention.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
Common Device Name
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON, DICKINSON & CO., (BD)
1575 airport road
sumter SC 29153
MDR Report Key7578868
Report Number1024879-2018-02163
Device Sequence Number13521710
Product Code JKA
UDI-Device Identifier50382903679817
UDI-Public50382903679817
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
BK050036
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Other
Device Expiration Date06/30/2016
Device Catalogue Number367981
Device Lot Number5163776
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/20/2015
Initial Report FDA Received Date06/07/2018
Patient Sequence Number1
Outcome Attributed to Adverse Event Death; Other;
-
-