BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION TUBE - SODIUM CITRATE

    MDR report key: 6984221 · Received October 27, 2017

    Report

    Report Number
    1917413-2017-00263
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Date of Event
    August 26, 2016
    Report Date
    October 6, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JCF
    UDI-DI
    50382903627603
    PMA / PMN Number
    K911731
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. RESULTS: A SAMPLE OR PHOTO IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION TUBE - SODIUM CITRATE  (13X100 MM / 4ML) TUBES WERE BREAKING DURING CENTRIFUGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764513 BD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION TUBE - SODIUM CITRATE SPECIMEN COLLECTION TUBE JCF BECTON, DICKINSON & CO. UNKNOWN 50382903627603

    Patients

    Seq Age Sex Outcome Treatment
    1 Other