BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHASEAL INFUSION ADAPTER

    MDR report key: 1945223 · Received December 21, 2010

    Report

    Report Number
    9615998-2010-00011
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 21, 2010
    Manufacturer
    CARMEL PHARMA AB.
    Product Code
    FPA
    PMA / PMN Number
    K023747
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED INCIDENT DOES NOT INVOLVE DEATH OR SERIOUS INJURY TO PT, USER OR OTHER PERSONS. THE SPIKE OF THE INFUSION ADAPTER IS MADE OF ABS PLASTIC (STATED IN INSTRUCTION FOR USE). SOME DRUGS OR DRUG SOLVENTS ARE KNOWN TO COMPROMISE THE INTEGRITY OF ABS PLASTIC. INVESTIGATIONS PERFORMED IN RELATION TO PREVIOUS REPORTS HAVE SHOWN THAT FRACTURES OF THE PHASEAL INFUSION ADAPTER C100 SPIKE MAY OCCUR AS THE RESULT OF INTERACTION BETWEEN THE INFUSION ADAPTER SPIKE, CERTAIN DRUG AND CERTAIN IV CONTAINER PORTS. A TECHNICAL BULLETIN WITH THIS INFO, TOGETHER WITH A RECOMMENDATION TO FLUSH THE INFUSION ADAPTER WITH DILUTED DRUG IMMEDIATELY AFTER INJECTION HAS BEEN ISSUED TO ALL US CUSTOMERS AS A RESULT OF EARLIER INVESTIGATIONS. THE INSTRUCTION FOR USE HAS BEEN REVISED ACCORDINGLY.

    Description of Event or Problem · 1

    INCIDENT REPORTED REGARDING INFUSION ADAPTER C100 FRACTURE WHEN PREPARED IN COMBINATION WITH BBRAUN PAB BAG CONTAINING TEMSIROLIMUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHASEAL INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET FPA CARMEL PHARMA AB. C100 10030728

    Patients

    Seq Age Sex Outcome Treatment
    1