BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4472489 · Received February 1, 2015

    Report

    Report Number
    1416980-2015-04014
    Event Type
    Malfunction
    Date Received
    February 1, 2015
    Date of Event
    December 28, 2014
    Report Date
    January 7, 2015
    Manufacturer
    SEE H10
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. THE INSPECTION OF A PHOTOGRAPH REVEALED THAT THE SPIKE WAS MALFORMED AS IT WAS INCOMPLETELY MOLDED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE DEFECTIVE RAW MATERIAL SUPPLIED BY AN INTERNAL SUPPLIER. TO ADDRESS THIS ISSUE, THE SUPPLIER WAS NOTIFIED AND A CAPA WAS OPENED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BURETROL SOLUTION ADMINISTRATION SET HAD TOO SMALL OF AN ENTRY POINT OR PORT. THIS WAS NOTED BEFORE PATIENT USE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73284 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA SEE H10 13L25V748

    Patients

    Seq Age Sex Outcome Treatment
    1