BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CTAD BLOOD COLLECTION TUBES

    MDR report key: 7556705 · Received May 31, 2018

    Report

    Report Number
    9617032-2018-01267
    Event Type
    Malfunction
    Date Received
    May 31, 2018
    Date of Event
    November 13, 2017
    Report Date
    June 9, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K991120
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE TYPE IS CORRECTED TO JKA. PMA / 510(K)# IS CORRECTED TO K991120.

    Additional Manufacturer Narrative · 1

    DATE DEVICE WAS RETURNED TO MANUFACTURER FOR EVAL: UNKNOWN. THE DATE BD WAS MADE AWARE OF THIS COMPLAINT HAS BEEN USED FOR THIS FIELD. (B)(6). BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE WITH THE INCIDENT LOT WAS NOT OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. BD HAS INITIATED A CAPA TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE(S) OF THIS PRODUCT ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® CTAD BLOOD COLLECTION TUBES HAD "UNDERFILL"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399713 BD VACUTAINER® CTAD BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 7093620

    Patients

    Seq Age Sex Outcome Treatment
    1 Other