BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ TUBES

    MDR report key: 7098403 · Received December 7, 2017

    Report

    Report Number
    9617032-2017-00597
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    May 23, 2017
    Report Date
    November 17, 2017
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE ATTACHED PHOTOGRAPHS SHOWS SEVERAL TUBES, ONE WITH THE CORRECT AMOUNT OF GEL BUT WITH AN AIR BUBBLE IN THE GEL, TWO WITH TWICE THE AMOUNT OF GEL, AND TWO WITH NO GEL. NO SIMILAR DEFECTS WERE IDENTIFIED IN THE (B)(4) RETAINED SAMPLES FROM THIS LOT NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT #7067956. CONCLUSION: BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODES WITH THE PHOTOGRAPHS PROVIDED. THE MOST LIKELY ROOT CAUSE FOR THE REPORTED DEFECT IS THAT A TUBE ALREADY CONTAINING GEL WAS USED TO EITHER INFILL A SPACE OR REPLACE A DEFECTIVE TUBE PRIOR TO THE GEL DISPENSE PROCESS, RESULTING IN A TUBE WITH TWICE THE REQUIRED AMOUNT OF GEL. THE EMPTY TUBES WERE PROBABLY INFILLED BY MISTAKE AFTER THE GELLING STAGE, WHILST THE BUBBLE WOULD HAVE BEEN CAUSED BY AIR IN THE DISPENSE SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® PST¿ TUBES HAD NO GEL, TOO MUCH GEL, AND BUBBLES IN THE GEL. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877191 BD VACUTAINER® PST¿ TUBES BLOOD COLLECTION TUBE JKA BECTON, DICKINSON AND COMPANY (BD) 7067956

    Patients

    Seq Age Sex Outcome Treatment
    1 Other