BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

    MDR report key: 7466322 · Received April 26, 2018

    Report

    Report Number
    1917413-2018-00799
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Date of Event
    January 16, 2017
    Report Date
    June 14, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903627887
    PMA / PMN Number
    K972075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER DETAILS IS CORRECTED TO: SEE EVENT DESCRIPTION BELOW. DESCRIBE EVENT OR PROBLEM IS CORRECTED TO:IT WAS REPORTED THAT BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG HAD CLOTTING ISSUES. NO SERIOUS INJURY OR MEDICAL INTERVENTION. MEDICAL DEVICE BRAND NAME CORRECTED TO: BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG. MEDICAL DEVICE CATEGORY # IS CORRECTED TO :362788. MEDICAL DEVICE LOT IS CORRECTED TO # 6216873. DATE RECEIVED BY MANUFACTURER CORRECTED TO: 01/16/2017. PMA / 510(K)# CORRECTED TO: K972075. DEVICE MANUFACTURE DATE CORRECTED TO: 08/03/2016.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG HAD CLOTTING ISSUES. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Additional Manufacturer Narrative · 1

    BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE FOR (B)(6) WAS NOT OBSERVED AS ALL SAMPLES MET SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES HAD CLOTTING IN TUBES

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307737 BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 6216873 50382903627887

    Patients

    Seq Age Sex Outcome Treatment
    1 Other