BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRY SKIN PREP TRAY

    MDR report key: 11697091 · Received April 20, 2021

    Report

    Report Number
    1423507-2021-00028
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 26, 2021
    Report Date
    November 12, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    OJU
    UDI-DI
    10885403142192
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    A PHOTO WAS PROVIDED FOR THE INVESTIGATION. WITH THE PHOTO PROVIDED, THE FAILURE MODE WAS CONFIRMED AS AN INSECT WAS OBSERVED ON THE TRAY. ACCORDING TO THE MANUFACTURE, THE ENVIRONMENT WAS REVIEWED AND NO ISSUES WERE FOUND, IN ADDITION ALL AREAS ARE FUMIGATED ACCORDING TO THEIR PROCEDURE AND HAS A STRONG PEST CONTROL MEASURES IN PLACE. TWICE A MONTH INSPECTIONS ARE CONDUCED AS WELL. A BATCH REVIEW WAS CONDUCTED AND THIS WAS THE FIRST COMPLAINT FOR THE REPORTED FAILURE MODE OF INSECT. AT THIS TIME, THE MANUFACTURE OF THE PRODUCT COULD NOT DETERMINE A ROOT CAUSE. H3 OTHER TEXT : SEE BELOW NARRATIVE SECTION.

    Description of Event or Problem · 0

    MATERIAL NO: 4461A BATCH NO: 0004165631. IT WAS REPORTED THAT A BUG WAS FOUND INSIDE OF THE KIT. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: I HOPE THINGS ARE WELL. I RECEIVED A PRODUCT COMPLAINT A MOMENT AGO CONCERNING A BUG FOUND IN THE CUSTOMER BELOWS PREP KIT. LOT NUMBER, PREP TRAY NUMBER, ETC IS ALL INCLUDED BELOW. LYNN WHO IS THE CUSTOMER AT THE ACCOUNT WHO LET US KNOW OF THE ISSUES EMAIL IS L[OMITTED] THE PRODUCT WAS NOT USED AN IMMEDIATELY DISCARDED. THANKS FOR ANY ASSISTANCE YOU CAN PROVIDE. HAVE A WONDERFUL DAY. YES, YOU READ THAT RIGHT. TODAY WE FOUND A BUG IN OUR PREP KIT. IT LOOKS TO HAVE BEEN STERILIZED ALONG WITH THE KIT AS IT WAS FOUND UNDER THE SPONGE STICKS, HOWEVER, WE CHOSE NOT TO USE IT. I ATTACHED A PICTURE OF THE PACKAGE LABEL INSERT AND THE STERILIZED CREATURE. DOES THIS GET FORWARDED TO BD? HOW DOES SOMETHING LIKE THIS GET HANDLED?

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    MATERIAL NO: 4461A, BATCH NO: 0004165631. IT WAS REPORTED THAT A BUG WAS FOUND INSIDE OF THE KIT. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: I HOPE THINGS ARE WELL. I RECEIVED A PRODUCT COMPLAINT A MOMENT AGO CONCERNING A BUG FOUND IN THE CUSTOMER BELOW'S PREP KIT. LOT NUMBER, PREP TRAY NUMBER, ETC IS ALL INCLUDED BELOW. LYNN WHO IS THE CUSTOMER AT THE ACCOUNT WHO LET US KNOW OF THE ISSUES EMAIL IS L[OMITTED] THE PRODUCT WAS NOT USED AN IMMEDIATELY DISCARDED. THANKS FOR ANY ASSISTANCE YOU CAN PROVIDE. HAVE A WONDERFUL DAY. YES, YOU READ THAT RIGHT. TODAY WE FOUND A BUG IN OUR PREP KIT. IT LOOKS TO HAVE BEEN STERILIZED ALONG WITH THE KIT AS IT WAS FOUND UNDER THE SPONGE STICKS, HOWEVER, WE CHOSE NOT TO USE IT. DOES THIS GET FORWARDED TO BD? HOW DOES SOMETHING LIKE THIS GET HANDLED?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592722 DRY SKIN PREP TRAY DRY SKIN PREP TRAY OJU CAREFUSION, INC 4461A 0004165631 10885403142192

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other