BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXPLUS CLEAR NEEDLELESS CONNECTOR

    MDR report key: 3122541 · Received May 16, 2013

    Report

    Report Number
    9616066-2013-00367
    Event Type
    Injury
    Date Received
    May 16, 2013
    Report Date
    April 30, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K072542
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER WAS INFORMED THAT THE MAXPLUS CLEAR NEEDLESS CONNECTOR DOES CONTAIN A SMALL AMOUNT OF SILICONE IN THE FLUID PATH. THE CUSTOMER REPORTED THAT THE PRODUCT AND SYRINGES WERE SENT TO VIROPHARMA, THE MANUFACTURER OF THE CINRYZE (C-1 ESTERASE INHIBITOR) FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT DETAILS BECOME KNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEIR DAUGHTER HAD AN ADVERSE REACTION AND FEELS THIS MAY BE RELATED TO THE MP1000-C. THE DRUG BEING ADMINISTERED IS CINRYZE (C-1 ESTERASE INHIBITOR). THE CUSTOMER WANTS TO KNOW IF THE VALVE CONTAINS EITHER SILICONE OIL OR NITRILE BECAUSE PER THE DRUG MANUFACTURER, VIROPHARMA, SILICONE OIL CAUSES CLOTTING WHEN IN CONTACT WITH THE MEDICATION. THE CUSTOMER STATED THIS PARTICULAR EVENT OCCURRED ABOUT AN HOUR AFTER THE CONNECTOR WAS REMOVED FROM THE PICC AND THE REACTION WITH THE CONNECTOR AND A SPECIFIC LOT NUMBER OF CINRYZE MAY HAVE HAPPENED COINCIDENTALLY. THE CUSTOMER INITIATED USE OF MP1000-C VALVES ON (B)(6) 2013 AFTER A VISIT TO THE EMERGENCY ROOM. PRIOR TO THIS THE CUSTOMER USED AN ICU MEDICAL CLAVE VALVE. THE REACTION WAS DESCRIBED AS ESOPHAGEAL/LARYNGEAL SWELLING WHICH SPREAD TO NECK, MOUTH, TONGUE, SINUSES, EYES AND THEN THE REST OF HER BODY INCLUDING HANDS AND FEET. TREATMENT PROVIDED WAS OXYGEN AT 4 LITERS, DIPHENHYDRAMINE, SOLU-CORTEF, 1000MG BERINERT (C-1 ESTERASE INHIBITOR-MFG BY CSL BEHRING) IV THROUGH A PICC LINE. THIS IS THE USUAL COURSE OF TREATMENT FOR BREAK THROUGH SWELLING; HOWEVER IT IS UNCLEAR WHETHER THIS REACTION WAS CAUSED BY AN ALLERGEN. NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217740 MAXPLUS CLEAR NEEDLELESS CONNECTOR FPA CAREFUSION CORPORATION MP1000-C UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention MANUFACTURERS, MODELS AND LOT NUMBERS UNKNOWN| SYRINGE| PICC LINE