BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER

    MDR report key: 7115129 · Received December 13, 2017

    Report

    Report Number
    9617032-2017-00645
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    March 30, 2016
    Report Date
    December 13, 2017
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER'S PHONE #: (B)(6). RESULTS: TWO (2) SAMPLES WERE RETURNED, AND EACH WAS USED TO DRAW 5 VACUTAINER TUBES WITH HORSE BLOOD FROM AN ELEVATED RESERVOIR TO SIMULATE VENOUS PRESSURE. ALL 10 TUBES DREW SATISFACTORILY, WITH THE NP SLEEVES RECOVERING THEIR NEEDLES BETWEEN TUBES, AND NO BLOOD LEAKAGE INTO THE HOLDERS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5140034. CONCLUSION: FUNCTION TESTING OF RETURNED NEEDLES DID NOT CONFIRM THE REPORTED DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER LEAKED FROM THE RUBBER SLEEVE AT THE BACK END OF THE NEEDLE. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891142 BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER BLOOD COLLECTION NEEDLE FMI BECTON, DICKINSON AND COMPANY (BD) 5140034

    Patients

    Seq Age Sex Outcome Treatment
    1 Other