BEUDAMED
    FDA Adverse Event Other Summary report: N

    NA

    MDR report key: 1010139 · Received March 10, 2008

    Report

    Report Number
    2647836-2008-00002
    Event Type
    Other
    Date Received
    March 10, 2008
    Date of Event
    February 8, 2008
    Report Date
    March 5, 2008
    Manufacturer
    B. BRAUN MEDICAL INC
    Product Code
    FMI
    PMA / PMN Number
    K895109
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICES IN THE REPORTED INCIDENTS WERE NOT RETURNED FOR EVAL. THIRTY SEVEN (37) UNUSED SEALED REP SAMPLES WERE RETURNED. THERE WERE NO VISIBLE CRACKS OR MFG DEFECTS NOTED WHEN MICROSCOPICALLY INSPECTED. THE HOUSE RETAIN SAMPLES FOR THE REPORTED PART WERE VISUALLY AND PHYSICALLY TESTED PER SPECIFICATION AND PASSED. ALTHOUGH SAMPLES WERE NOT RETURNED OF THE MATING REPORTED IV SET FOUR (4) SAMPLES WERE PULLED FROM CURRENT B. BRAUN INVENTORY TO PERFORM TESTING WITH THE UNUSED REPORTED CRACKED PROTECTED NEEDLE SAMPLES. FOUR PROTECTED NEEDLES WERE ATTACHED TO FOUR IV SETS. THE ASSEMBLIES WERE PRESSURE TESTED AND NO LEAKS WERE NOTED AT THE CONNECTION OF THE NEEDLE TO THE ADAPTER OF THE IV SET. THE NEEDLES WERE THEN EXAMINED FOR CRACKS. NO CRACKS WERE NOTED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THE UNUSED SAMPLES AND ALL AVAILABLE INFO HAVE BEEN PROVIDED TO THE ACTUAL MFR, ICU MEDICAL, INC. IF ANY PERTINENT INFO BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE DISTRIBUTOR, PER THE END USER FACILITY: WHEN THE STAFF CONNECTS N2319-100 TO PROD V1443, THE INFUSING IV SOLUTION STARTS TO LEAK FROM THE FEMALE END OF PROD N2319-100. CUSTOMER STATES "I THINK THERE IS A CRACK IN THE PROTECTED NEEDLE", SOME INFUSIONS CONTAIN CHEMO DRUGS. ADD'L INFO PROVIDED BY THE FACILITY INDICATED THAT NO PT OR STAFF MEMBERS SUFFERED ANY ADVERSE SEQUELA ASSOCIATED WITH THE INCIDENTS. UNUSED SAMPLES WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA PROTECTED NEEDLE FMI B. BRAUN MEDICAL INC NA 60956134

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK