BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEX PRESSURE INFUSION CLEAR CUFF

    MDR report key: 15392882 · Received September 9, 2022

    Report

    Report Number
    3012307300-2022-18328
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Date of Event
    January 11, 2020
    Report Date
    September 9, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    KRK
    UDI-DI
    10351688507037
    PMA / PMN Number
    K904674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. PRODUCT SAMPLES WERE RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. TWO PRODUCTS WERE RECEIVED, EACH UNIT RETURNED APPEARS ASSEMBLED CORRECTLY. UNIT HAS NO PHYSICAL MARKINGS OR DAMAGE NOTED. REPORTED PROBLEM WAS CONFIRMED THE ROOT CAUSE OF THE REPORTED ISSUE WAS FOUND TO BE LEAKING IN THE SUB ASSEMBLY PORTION MANUFACTURED IN THE FACILITY. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL B10009406, AS A RESULT OF WARNING LETTER CMS# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NO PRESSURE BUILD-UP WAS POSSIBLE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1578069 MEDEX PRESSURE INFUSION CLEAR CUFF MANOMETER, BLOOD-PRESSURE, VENOUS KRK SMITHS MEDICAL ASD, INC. MX4705 4079471 10351688507037

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown