BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IP PREP SKIN TRAY

    MDR report key: 10630124 · Received October 5, 2020

    Report

    Report Number
    1423507-2020-00046
    Event Type
    Malfunction
    Date Received
    October 5, 2020
    Date of Event
    September 8, 2020
    Report Date
    November 25, 2020
    Manufacturer
    CAREFUSION, INC
    Product Code
    OJU
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTOS HAVE BEEN PROVIDED FOR EVALUATION. THE PHOTOS SHOW THE USER HANDS COVERED IN A SUBSTANCE; WHICH MIGHT BE LINKED TO HOLES ON THE GLOVES PROVIDED WITH THE KIT. AS FOR IMAGES ON THE ACTUAL HOLES ON GLOVES; THAT WAS NOT CONFIRMED. PERSONNEL, MANUFACTURING PROCESS, EQUIPMENT AND THE ENVIRONMENT ARE NOT RELATED TO THE REPORTED DEFECT. THE ACTUAL GLOVES (PART NUMBER 76-89) WITHIN THE FINISHED GOODS PRODUCT 4468 ARE SUPPLIED OUTSIDE OF BD. INSPECTION PERFORMED MATERIAL REVIEW BASED ON INTERNAL PROCEDURES WITH NO REJECTIONS. A SUPPLIER CORRECTIVE ACTIONS REPORT HAS BEEN SENT TO THE SUPPLIER (BALDUR SYSTEMS CORP) FOR THE GLOVES AND THEY WILL BE ASKED TO START AN INVESTIGATION TO DETERMINE A ROOT CAUSE. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GLOVES THAT COME WITH THE SKIN PREP KITS HAVE HOLES IN THEM.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GLOVES THAT COME WITH THE SKIN PREP KITS HAVE HOLES IN THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090969 IP PREP SKIN TRAY SKIN SCRUB TRAY OJU CAREFUSION, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other