BEUDAMED
    FDA Adverse Event Summary report: N

    EZ-IO MANUAL NEEDLE SET

    MDR report key: 2571351 · Received August 31, 2010

    Report

    Report Number
    3004526033-2010-00004
    Date Received
    August 31, 2010
    Date of Event
    January 1, 2010
    Report Date
    July 21, 2010
    Manufacturer
    VIDACARE CORPORATION
    Product Code
    FMI
    PMA / PMN Number
    K052195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VIDACARE BECAME AWARE OF A REPORT OF A PERFORATION OF A PT'S STERNUM BY A VIDACARE 25MM IO NEEDLE SET FROM A REPORT TITLED "FEEDBACK TO THE FIELD" CREATED BY INDIVIDUALS FROM (B)(6). THE REPORT INDICATED THAT DURING EMERGENCY TREATMENT OF A SERIOUSLY WOUNDED SOLDIER A MANUAL OR POSSIBLY A POWERED ADULT 25MM LENGTH IO NEEDLE SET WAS PLACED IN AND THROUGH THE STERNUM. PLACEMENT OF A MANUAL 25MM LENGTH NEEDLE SET WAS OFF LABEL AND CONTRAINDICATED BY EXPLICIT LABELING SUPPLIED WITH THE MANUAL DEVICE IN THREE SEPARATE PACKAGE LOCATIONS: OUTSIDE PACKAGE LABEL, INSTRUCTIONS FOR USE AND A WARNING LABEL WHICH IS WRAPPED AROUND THE MANUAL NEEDLE SET. IN ADDITION THE TWO DEVICES ARE COLOR CODED AND HAVE VERY DIFFERENT ERGONOMIC DESIGN TO FURTHER DIFFERENTIATE THE MANUAL FROM THE STERNAL PRODUCT. THE POWERED 25MM NEEDLE SET IS LABELED TO INDICATE USE IN 6 LOCATIONS (HUMERUS, AND BOTH DISTAL AND PROXIMAL ENDS OF THE TIBIA).

    Description of Event or Problem · 1

    PERFORATION OF THE STERNUM BY A 25MM EZ-IO NEEDLE SET CONTRARY TO INDICATIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ-IO MANUAL NEEDLE SET INTRAOSSEOUS NEEDLE SET FMI VIDACARE CORPORATION 9055 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Life Threatening EZ-IO 45MM INTRAOSSEOUS NEEDLE SET X 2