BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAY-COT

    MDR report key: 9734934 · Received February 20, 2020

    Report

    Report Number
    1221144-2019-00001
    Event Type
    Malfunction
    Date Received
    February 20, 2020
    Date of Event
    December 12, 2019
    Report Date
    January 3, 2020
    Manufacturer
    AMERICAN SURGICAL COMPANY
    Product Code
    HBA
    PMA / PMN Number
    K902921
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF MANUFACTURING RECORDS FOUND NO DISCREPANCIES. THE CUSTOMER WAS UNABLE TO PROVIDE THE EXACT LOT NUMBER FOR THE DEVICE. THERE RECORDS SHOW THREE LOT NUMBERS ON HAND. THE COMPLAINT DEVICE WAS USED AND IS UNABLE TO BE TESTED, HOWEVER, REFERENCE SAMPLES RETAINED BY ASC WERE TESTED FROM THE THREE LOT NUMBERS PROVIDED BY THE CUSTOMER. ALL SAMPLES TESTED MET ACCEPTANCE CRITERIA. ON (B)(6) 2020 UNUSED DEVICES WERE RETURNED TO ASC BY THE CUSTOMER. SAMPLES FROM THE RETURNED DEVICES WERE ALSO TESTED. ALL SAMPLES TESTED MET ACCEPTANCE CRITERIA. AT THIS TIME WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE IDENTIFICATION THREAD DETACHED FROM THE SURGICAL SPONGE. THERE WAS NO REPORTS OF DELAY OR PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199676 RAY-COT NEUROSURGICAL SPONGE HBA AMERICAN SURGICAL COMPANY LOT NUMBER UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention