BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYTEC

    MDR report key: 3118766 · Received May 8, 2013

    Report

    Report Number
    3118766
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 8, 2013
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL SET UP, SCRUB TECH OPENED CUSTOM SURGICAL PACKS AND NOTICED RAYTEC SPONGE THREADS FRAYING APART. THE SPONGES WERE REMOVED FROM STERILE SET UP BEFORE SURGERY AND SAVED. THIS EVENT WAS NOTED IN THREE DIFFERENT CUSTOM CARDINAL SURGICAL PACKS. NO PATIENTS WERE HARMED.======================MANUFACTURER RESPONSE FOR RAYTEC SPONGES, SPONGE, GAUZE XRAY (PER SITE REPORTER).======================PACKS CONTAINING SPONGES ARE HYBRIDS WITH PORTION FROM CARDINAL & SRI/SYNERGY HEALTH - BOTH NOTIFIED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?NA.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #3IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202248 RAYTEC GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE GDY CARDINAL HEALTH * *
    202249 RAYTEC GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE GDY CARDINAL HEALTH * *
    202250 RAYTEC GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE GDY CARDINAL HEALTH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *