BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLELESS INJECTION SITE MASTER ADAPTER

    MDR report key: 96621 · Received May 16, 1997

    Report

    Report Number
    MW4001914
    Event Type
    Injury
    Date Received
    May 16, 1997
    Date of Event
    May 11, 1997
    Report Date
    May 14, 1997
    Manufacturer
    CRITICAL DEVICE CORP.
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS WAS THE INJECTION CAP ON A PICC FOR IV VANCOMYCIN. THE PICC WAS PULLED OUT APPROX 6" DURING THE NIGHT. THE PT WAS CONNECTED TO A PUMP.WHEN THE ACCESS WAS EVALUATED IT WAS NOTED THAT THE DIAPHRAM OF THE NIMA WAS INVERTED. THIS COULD ALLOW AIR ENTRY OR BLOOD BACK-UP IN THE PICC. RPTR WAS UNABLE TO FLUSH THE PICC. RECOMMENDED IT BE PULLED DUE TO QUESTIONABLE INTEGRITY OF THE LINE. THE PT REFUSED FURTHER NEEDLE STICKS. THERAPY WAS DISCONTINUED ONE WEEK EARLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEEDLELESS INJECTION SITE MASTER ADAPTER HEPARIN LOCK ADAPTER FOZ CRITICAL DEVICE CORP. * CF600

    Patients

    Seq Age Sex Outcome Treatment
    1 *