BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHASEAL INFUSION ADAPTER

    MDR report key: 1083076 · Received July 23, 2008

    Report

    Report Number
    9615998-2008-00003
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 17, 2008
    Report Date
    June 23, 2008
    Manufacturer
    CARMEL PHARMA AB.
    Product Code
    FPA
    PMA / PMN Number
    K023747
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED INCIDENT DO NOT INVOLVE DEATH OR INJURY TO PATIENT, USER OR OTHER PERSON. THE RISK OF POTENTIAL DEATH OR SERIOUS INJURY IS CONSIDERED NEGLIGIBLE. INVESTIGATIONS PERFORMED IN RELATION TO PREVIOUS REPORTS HAVE SHOWN THAT FRACTURES OF THE PHASEAL INFUSION ADAPTER C100 SPIKE MAY OCCUR AS A RESULT OF INTERACTION BETWEEN THE INFUSION ADAPTER SPIKE, CERTAIN DRUGS AND CERTAIN IV CONTAINER PORT. THE PREVIOUSLY REPORTED INCIDENTS WITH FRACTURED C100 SPIKES HAVE OCCURRED IN COMBINATION WITH BBRAUN PAB IV CONTAINERS WITH RIGID SPIKE PORTS. THERE WAS NO EVIDENCE THAT THE UNDILUTED DRUG (TAXOL) MAY CAUSE FRACTURE OF THE C100 SPIKE, UNLESS THE DRUG AND SPIKE WAS USED IN COMBINATION WITH THE MENTIONED IV CONTAINER. A TECHNICAL BULLETIN WITH THIS INFORMATION 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 INVESTIGATION. THE INSTRUCTION FOR USE WAS REVISED ACCORDINGLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN THE NURSE WAS SPIKING THE IV LINE TO THE INFUSION ADAPTER C100 AND THE 100 ML BBRAUN PAB IV CONTAINER, THE C100 SPIKE BROKE OFF. THE INVOLVED DRUG WAS TAXOL. NO SPILLAGE OF DRUG. NO PATIENT OR USER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHASEAL INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET FPA CARMEL PHARMA AB. C100 8150339

    Patients

    Seq Age Sex Outcome Treatment
    1