BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTOR Q SYTE

    MDR report key: 4972684 · Received July 6, 2015

    Report

    Report Number
    4972684
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Date of Event
    April 17, 2015
    Report Date
    July 6, 2015
    Manufacturer
    BD
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN THE NICU, WE EXPERIENCED 4 INSTANCES OF IV FLUIDS LEAKING AROUND THE BD Q SYTE- 2 APPEARED CRACKED, THROUGH PICC LINES AND PCVC LINE. TPN AND PLAIN IV SOLUTIONS WERE ADMINISTERED. ONE BABY REQUIRED A FLUID BOLUS. NO OTHER HARM TO INFANTS.======================MANUFACTURER RESPONSE FOR ADAPTOR Q SYTE LUER ACCESS, ADAPTOR Q SYTE LUER ACCESS (PER SITE REPORTER).======================WE REMOVED THE NOTED LOT NUMBERS; MADE ARRANGEMENTS FOR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434457 ADAPTOR Q SYTE SET, ADMINISTRATION, INTRAVASCULAR FPA BD * 4091005
    434458 ADAPTOR Q SYTE SET, ADMINISTRATION, INTRAVASCULAR FPA BD * 4237935

    Patients

    Seq Age Sex Outcome Treatment
    1 * IV/PICC ADMINISTRATION OF FLUIDS