BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML

    MDR report key: 7433314 · Received April 16, 2018

    Report

    Report Number
    1917413-2018-00764
    Event Type
    Malfunction
    Date Received
    April 16, 2018
    Date of Event
    October 25, 2016
    Report Date
    June 9, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JCF
    PMA / PMN Number
    K891407
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). BD RECEIVED TWO EXPIRED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. NO TESTING WILL BE PERFORMED ON EXPIRED PRODUCT. THIS IS FIRST COMPLAINT REPORTED WITH REGARDS TO THIS LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE TYPE IS CORRECTED TO JCF. PMA/510(K)# IS CORRECTED TO K891407.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML THE CUSTOMER WAS OBSERVING A LOW YIELD (10% TO 40% OF PBMCS INSTEAD OF 63%) DUE TO A LOW DRAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277918 BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML BLOOD SPECIMEN COLLECTION DEVICE JCF BECTON, DICKINSON & CO. 5275737

    Patients

    Seq Age Sex Outcome Treatment
    1 Other