BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A PLUS INTERNATIONAL

    MDR report key: 7328613 · Received March 9, 2018

    Report

    Report Number
    3004513970-2018-00001
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Date of Event
    January 26, 2018
    Report Date
    March 8, 2018
    Manufacturer
    A PLUS INTERNATIONAL
    Product Code
    EFQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RESOURCE OPTIMIZATION AND INNOVATION, LLC IS A REGISTERED CONVENIENCE KIT MANUFACTURER. THE COMPONENT, A BULK NON-STERILE FINISHED MEDICAL DEVICE (LAP SPONGE) IS USED IN THE KIT AS RECEIVED FROM THE COMPONENT MANUFACTURER (A-PLUS INTERNATIONAL, (B)(4)). THE KIT IS ASSEMBLED, STERILIZED AND SUPPLIED STERILE AS SINGLE-USE KITS FOR PATIENT USE. THE COMPONENT WAS A LAP SPONGE 18X18 PRE-WASHED LOOK BANDED 5, CATALOG NO. LS-1818-FS, LOT NO. 405921, 510(K) NO. 881395. THE BLUE CORD BROKE OFF OF THE LAP SPONGE AND THE RUBBER BAND AOURND LAP SPONGES DISINTEGRATED. THIS WAS IDENTIFIED WHILE USING THE SPONGES ON A PATIENT.

    Description of Event or Problem · 1

    BLUE CORD BROKE OFF OF LAP SPONGE AND RUBBER BAND AROUND THE LAP SPONGES WAS DISINTEGRATING.THIS WAS IDENTIFIED WHILE USING THE SPONGES ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172469 A PLUS INTERNATIONAL LAP SPONGE EFQ A PLUS INTERNATIONAL N/A 405921

    Patients

    Seq Age Sex Outcome Treatment
    1