BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETY-LOK¿ BLOOD COLLECTION WINGSET 23G X .75 IN, W/ 7 IN TUBING

    MDR report key: 7059142 · Received November 27, 2017

    Report

    Report Number
    1024879-2017-00273
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 28, 2015
    Report Date
    November 1, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    K980414
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). RESULTS: NO SAMPLES OR PHOTOS WERE RETURNED TO BD FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5090897. CONCLUSION: NOT CONFIRMED. WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS¿ INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BLOOD SAMPLE DRAW, USING A BD SAFETY-LOK¿ BLOOD COLLECTION WINGSET 23G X .75 IN, WITH 7 IN TUBING AND PRE-ATTACHED HOLDER, THAT BLOOD FLOWED THROUGH TUBING AND DRIPPED ONTO FLOOR BEFORE SERUM TUBE COULD BE USED. NO SERIOUS INJURY, BLOOD TO MUCOUS MEMBRANE EXPOSURE OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840932 BD SAFETY-LOK¿ BLOOD COLLECTION WINGSET 23G X .75 IN, W/ 7 IN TUBING BLOOD COLLECTOR JKA BECTON, DICKINSON & CO., (BD) 5090897

    Patients

    Seq Age Sex Outcome Treatment
    1 Other