BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC

    MDR report key: 3000046 · Received February 6, 2013

    Report

    Report Number
    1625425-2013-00002
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    FOZ
    PMA / PMN Number
    K944685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS REPORTED TO BECTON DICKENSON BY (B)(6). CUSTOMER INFORMATION IS CONFIDENTIAL AND NO FURTHER INFORMATION WAS PROVIDED FOR THIS INCIDENT. PRODUCT IS QUESTION WAS NOT RETURNED TO ARGON MEDICAL FOR EVALUATION. THE PRODUCT FEMA, THE LOT DEVICE HISTORY RECORD AND THE INSPECTION RECORD WERE REVIEWED FOR ANY DISCREPANCY REPORTS AND NO ANOMALY WAS FOUND. AN EXACT ROOT CAUSE IS UNABLE TO BE DETERMINED SINCE THE SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION AND NO FURTHER INFORMATION WAS PROVIDED FOR THE EVALUATION.

    Description of Event or Problem · 1

    SAMPLES ARE NOT AVAILABLE. PICC BREAK IN THE VESSEL. IT WAS SURGICALLY REMOVED. THE SECOND OCCURRENCE WAS THE BREAK ON THE OUTSIDE OF THE VESSEL, NECESSITATING THE REMOVAL AND THE PATIENT UNDERGO NEW PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49978 FIRST PICC PICC FOZ ARGON MEDICAL DEVICES, INC. NA 1307363

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other