BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

    MDR report key: 7527558 · Received May 18, 2018

    Report

    Report Number
    1917413-2018-01005
    Event Type
    Malfunction
    Date Received
    May 18, 2018
    Date of Event
    March 20, 2017
    Report Date
    May 22, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903679602
    PMA / PMN Number
    K911731
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER DETAILS WAS CORRECTED TO "SEE EVENT DESCRIPTION BELOW". EVENT OR PROBLEM DESCRIPTION WAS CORRECTED TO "IT WAS REPORTED THAT THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE HAD DIFFICULTY OBTAINING PBMCS AND THE EXPECTED RING OF CELLS AFTER CENTRIFUGATION. NO SERIOUS INJURY OR MEDICAL INTERVENTION." MEDICAL DEVICE BRAND NAME WAS CORRECTED TO BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE. UNIQUE IDENTIFIER (UDI)# CORRECTED TO (B)(4). DEVICE AVAILABLE FOR EVALUATION IS CORRECTED TO NO. PMA / 510(K)# WAS CORRECTED TO K911731. THIS SECTION IS CORRECT TO BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE HAD DIFFICULTY OBTAINING PBMCS AND THE EXPECTED RING OF CELLS AFTER CENTRIFUGATION. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEBD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) BLOOD COLLECTION TUBES HAD PROBLEMS LIKE: CUSTOMER REPORTING CPT SUPPLY DISSATISFACTION. NO SERIOUS INJURY MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367795 BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. UNKNOWN 50382903679602

    Patients

    Seq Age Sex Outcome Treatment
    1 Other