BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23 G X .75 IN. BD VACUTAINER® PBBCS WITH 12 IN. TUBING AND LUER ADAPTER

    MDR report key: 7059978 · Received November 27, 2017

    Report

    Report Number
    1024879-2017-00517
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    July 12, 2016
    Report Date
    October 25, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    00382903673421
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL SAMPLE WAS DISCARDED. BD RECEIVED REPRESENTATIVE SAMPLES FROM CUSTOMER TOTALLING 56 SAMPLES FROM SAME LOT# 6132861. ALL 56 WERE EVALUATED UNDER PRESSURIZED CONDITIONS FOR CUSTOMERS' INDICATED FAILURE MODE FOR LEAKAGE IN TUBING AND HUBS. NO DEFECTS OR LEAKAGE ON ALL 56 RETURNED SAMPLES WAS OBSERVED AND COULD NOT CONFIRM CUSTOMERS' INDICATED FAILURE MODE. A REVIEW OF THE MANUFACTURING RECORD WAS COMPLETED FOR LOT# 6132861, WHICH SHOWED ALL INSPECTIONS WERE IN COMPLIANCE WITH REQUIREMENTS. THIS IS A UNCONFIRMED COMPLAINT FOR THIS LOT# 6132861. BD HAS INITIATED A CAPA TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE(S) OF THIS PRODUCT ISSUE. REFER TO CAPA (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHLEBOTOMIST OBSERVED BLOOD LEAKING FROM WHERE THE TUBING MEETS THE BARREL AREA OF THE 23 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH 12 IN. TUBING AND LUER ADAPTER. NO SERIOUS INJURY, BLOOD TO MUCOUS MEMBRANE EXPOSURE OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838802 23 G X .75 IN. BD VACUTAINER® PBBCS WITH 12 IN. TUBING AND LUER ADAPTER BLOOD COLLECTION SET JKA BECTON, DICKINSON & CO., (BD) 6132861 00382903673421

    Patients

    Seq Age Sex Outcome Treatment
    1 Other