BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANOMETER TRAY STERILE 10/BX

    MDR report key: 9072587 · Received September 16, 2019

    Report

    Report Number
    1625685-2019-00110
    Event Type
    Malfunction
    Date Received
    September 16, 2019
    Date of Event
    August 27, 2019
    Report Date
    September 20, 2019
    Manufacturer
    CAREFUSION, INC
    Product Code
    KRK
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS RECORD IS NOT AN MDR. CUSTOMER CLARIFIED THERE WAS NO PACKAGE DEFECT, INSTEAD THE ISSUE WAS A 1PC SHORT COUNT.

    Description of Event or Problem · 0

    PACKING DISCREPANCY. ADDITIONAL INFORMATION RECEIVED (B)(6) 2019, THE RCC CLARIFIED: CUSTOMER FOUND PACKAGING WERE UNSEALED AT THE CORNER PRIOR USAGE. THE DEFECT WERE FOUND AT DISTRIBUTOR SITE HENCE THIS IS RAISING PACKAGING STERILITY CONCERNS AND THEY CAN¿T SHIP IT TO HOSPITALS. I AM REQUESTING DISTRIBUTOR WHETHER THEY ARE ABLE TO RETURN 1PC DEFECT SAMPLE BACK TO PLANT SITE.

    Additional Manufacturer Narrative · 1

    (B)(4). IF FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PACKING DISCREPANCY. ADDITIONAL INFORMATION RECEIVED 12SEPT2019, THE RCC CLARIFIED: CUSTOMER FOUND PACKAGING WERE UNSEALED AT THE CORNER PRIOR USAGE. THE DEFECT WERE FOUND AT DISTRIBUTOR SITE HENCE THIS IS RAISING PACKAGING STERILITY CONCERNS AND THEY CANT SHIP IT TO HOSPITALS. I AM REQUESTING DISTRIBUTOR WHETHER THEY ARE ABLE TO RETURN 1PC DEFECT SAMPLE BACK TO PLANT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866653 MANOMETER TRAY STERILE 10/BX MANOMETER, BLOOD-PRESSURE, VENOUS KRK CAREFUSION, INC 1286926

    Patients

    Seq Age Sex Outcome Treatment
    1 Other