BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEG NEEDLE

    MDR report key: 3619229 · Received February 5, 2014

    Report

    Report Number
    MW5034234
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    January 23, 2014
    Report Date
    February 4, 2014
    Manufacturer
    BARD
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS (B)(6) FEMALE WITH HISTORY OF SEIZURES, ATRIAL FIBRILLATION ON COUMADIN AND CAD (CORONARY ARTERY DISEASE), PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2014 WITH LEFT SIDED WEAKNESS ASSOCIATED WITH ALTERED MENTAL STATUS. THE PATIENT WAS ADMITTED WITH AN ACUTE ISCHEMIC STROKE IN THE POSTERIOR INFARCT AND RIGHT CEREBELLAR HEMISPHERE. SHE WAS MAINTAINED ON NPO (NO FOOD BY MOUTH) STATUS AND RECEIVED NUTRITION VIA NG (NASOGASTRIC) TUBE. PEG (PERCUTANEOUS ENDOSCOPIC GASTROTOMY) PLACEMENT WAS COMPLETED ON (B)(6) 2014 AT WHICH TIME THE PEG NEEDLE BENT TO A 90 DEGREE ANGLE. THE NEEDLE WAS REMOVED/RETRIEVED AND THE PROCEDURE ENSUED UTILIZING ANOTHER KIT/NEEDLE; NO FURTHER COMPLICATIONS WERE NOTED. THE PATIENT WAS TRANSFERRED BACK TO A NURSING HOME ON (B)(6) 2014 WITH INSTRUCTIONS TO FOLLOW-UP WITH THE NEUROLOGY TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75787 PEG NEEDLE NEEDLE KNT BARD HUXJ0984

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR