BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADD® ADMINISTRATION SETS

    MDR report key: 6304782 · Received February 6, 2017

    Report

    Report Number
    3012307300-2017-00415
    Event Type
    Injury
    Date Received
    February 6, 2017
    Date of Event
    September 18, 2016
    Report Date
    January 12, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    PMA / PMN Number
    K933390
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VOLUNTARY MEDWATCH SUBMISSION #: MW5066816. CUSTOMER HAS NOT RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CADD® ADMINISTRATION SET HAD MEDICATION SQUIRTING WHERE THE TUBING CONNECTED TO THE CARTRIDGE AND THE TUBING WAS LEAKING AT THE HUB SITE. THE INCIDENT OCCURRED WITH A HOME CARE PATIENT. THE MEDICATION IN USE FOR ADMINISTRATION WAS "AJ-PIP/TAZ." IT WAS NOTED THAT THE PATIENT WOKE UP IN A PUDDLE OF MEDICATION FROM THE REPORTED DEVICE ISSUE. APPROXIMATELY ONE-FOURTH OF THE MEDICATION REMAINED IN THE BAG AFTER THE INCIDENT. DUE TO THE INCIDENT, THE PATIENT WAS DIAPHORETIC AND REPORTED THAT HE WAS NOT FEELING WELL. THE ADMINISTRATION SET WAS REPLACED. IT WAS UNCLEAR WHAT THE IMPACT TO THE PATIENT WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86174 CADD® ADMINISTRATION SETS SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| S