BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURLINE

    MDR report key: 9255583 · Received October 30, 2019

    Report

    Report Number
    9255583
    Event Type
    Malfunction
    Date Received
    October 30, 2019
    Date of Event
    September 18, 2019
    Report Date
    September 23, 2019
    Manufacturer
    PRECISION DYNAMICS CORPORATION
    Product Code
    ISR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WE CURRENT USE PRECISION DYNAMICS CORPORATION SECURLINE BLOOD BANDS. SEVERAL OF THE ARMBANDS CONTAINED 2 DISTINCT NUMBERS, WHEN THE BAND SHOULD ONLY HAVE ONE NUMBER. THESE BANDS ARE USED TO IDENTIFY ALL OUR PATIENTS WHO ARE TO RECEIVE BLOOD AND BLOOD PRODUCTS AND THIS DEFECT COULD POTENTIALLY LEAD TO THE INCORRECT PATIENT RECEIVING BLOOD OR A PATIENT RECEIVING THE INCORRECT BLOOD TYPE. TWO PATIENTS HAD TO BE REDRAWN AND RE-BANDED PRIOR TO RECEIVING BLOOD. MANUFACTURER RESPONSE FOR ARMBAND, SECURLINE BLOOD BAND (PER SITE REPORTER). THEY HAVE REQUESTED ADDITIONAL INFORMATION AND PICTURES OF THE PRODUCT DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049965 SECURLINE BAND OR BELT, PELVIC SUPPORT ISR PRECISION DYNAMICS CORPORATION 8655438

    Patients

    Seq Age Sex Outcome Treatment
    1 26645 DA