BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRICULAR BOLT ICP MONITOR KIT W/ CRANIAL ACCESS

    MDR report key: 4180726 · Received October 15, 2014

    Report

    Report Number
    2023988-2014-00052
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Report Date
    September 19, 2014
    Manufacturer
    INTEGRA PAIN MGMT
    Product Code
    GWM
    PMA / PMN Number
    K914735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE NURSE IN THE NEURO INTENSIVE CARE UNIT OPENED A CONVENIENCE KIT FOR THE PHYSICIAN TO USE ON A PT AT THE BEDSIDE. WHEN THEY PULLED OUT THE CONTENTS OF THE 1104HMC, THERE WAS NO HM CATHETER OR VENTRICULAR DRAINAGE SYSTEM. INSTEAD, THERE WAS A PARENCHYMAL CATHETER. THE CRANIAL ACCESS KIT WAS THERE, AS EXPECTED, BUT IT WAS BASICALLY THE CONTENTS OF A 1104BC CONVENIENCE KIT INSTEAD OF A 1104HMC AS IT WAS LABELED. THIS CAUSED A DELAY IN THE PROCEDURE AS THEY HAD TO GO TO ANOTHER UNIT IN THE HOSP TO GET A REPLACEMENT KIT. THEY THREW AWAY EVERYTHING BUT THE UNOPENED CRANIAL ACCESS KIT. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653677 VENTRICULAR BOLT ICP MONITOR KIT W/ CRANIAL ACCESS NA GWM INTEGRA PAIN MGMT 98816

    Patients

    Seq Age Sex Outcome Treatment
    1