BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC, SINGLE LUMEN

    MDR report key: 6070694 · Received November 1, 2016

    Report

    Report Number
    1625425-2016-00077
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Report Date
    November 1, 2016
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    FOZ
    PMA / PMN Number
    K972262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FOUR UNOPENED SAMPLES WERE RETURNED FROM THE CUSTOMER. A PHYSICAL REVIEW WAS CONDUCTED, BUT THERE WERE NO ISSUES NOTED, SO THE COMPLAINT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORDS, INSPECTION RECORDS, AND NON-CONFORMING DATABASE WAS CONDUCTED AND NO SIMILAR CONCERNS WERE FOUND. THE COMPLAINT WAS NOT CONFIRMED, SO NO FURTHER EVALUATION WILL BE CONDUCTED AT THIS TIME. FIRST PICC CATHETERS ARE 100% IN-PROCESS INSPECTED AT VARIOUS TIMES DURING MANUFACTURE. CATHETERS ARE ALSO LEAK, FLOW, AND BURST TESTED TO ENSURE THEIR INTEGRITY. ADDITIONALLY, THE INSTRUCTIONS FOR USE INDICATE SEVERAL WAYS USERS CAN MITIGATE THE OCCURRENCE OF BREAKAGE.

    Description of Event or Problem · 1

    AFTER AN X-RAY PROCEDURE, THE NURSE IDENTIFIED THAT THE PICC CATHETER WAS BROKEN AT THE BASE OF THE BUTTERFLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722072 FIRST PICC, SINGLE LUMEN FIRST PICC FOZ ARGON MEDICAL DEVICES INC. 11090641

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention