BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BBG

    MDR report key: 1293732 · Received January 15, 2009

    Report

    Report Number
    MW5009646
    Event Type
    Injury
    Date Received
    January 15, 2009
    Date of Event
    January 1, 2009
    Report Date
    January 15, 2009
    Manufacturer
    CHILDRENS MEDICAL VENTURES
    Product Code
    JOL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    I AM A MEDICAL PROFESSIONAL AND AM CONCERNED OVER THE MISREPRESENTATION OF TWO PRODUCTS BEING USED INT HE NEONATAL INTENSIVE CARE UNITS. BY MEDICAL VENTURES - A PHILLIPS COMPANY- AND THE LITTLE SUCKER BY NEOTECH. BOTH THESE DEVICES MAKE THE CLAIM THAT THEY CAN BE USED ORALLY AND NASALLY. THE PROBLEM IS THAT EACH HAVE A SINGLE HOLE ON THE DISTAL END. THE MOMENT THESE DEVICES ARE PLACED INTO THE MOUTH OF A PRE-TERM INFANT, THE PT IS AT GREAT RISK OF HAVING TRAUMA CAUSED BY THE SUCTION HOLE MAKING DIRECT CONTACT WITH THE FRIABLE TISSUE IN THE MOUTH OF THE PRETERM INFANT. I HAVE SEEN POCKETS OF MUCOUSA TORN OUT OF THE BACK OF THE THROAT OF THESE TINY BABIES AND THIS DELAYS THE INFANT FROM DEVELOPING A SUCK SWALLOW REACTION. IT CAN ALSO LEAD TO PROLONGED STAYS IN THE INTENSIVE CARE AND THE HOSPITAL. IT SHOULD BE NOT ALLOWED TO USE A SINGLE HOLE DEVICE IN THE MOUTH OF ANY PT IN THE HOSPITAL. THIS HAS BEEN A PROBLEM FOR YEARS AND ONE THAT HAS BEEN IGNORED BY MEDICAL PERSONNEL BECAUSE IT IS HARM THAT IS UNSEEN. I HAVE PHOTOGRAPHS OF DEVICES HAND-MADE BY MEDICAL PERSONNEL IN ORDER TO SUCTION THE THICK SECRETIONS FROM THE BABIES MOUTH WHEN THEY ARE ON A MECHANICAL VENTILATOR. MEDICAL STAFF ARE USING A TB SYRINGE AND ALTERING IT AND HOOKING IT UP TO SUCTION, THIS ONE IS PROBABLY THE MOST COMMON MISUSE, BUT THERE ARE OTHERS AND IT IS OUTRAGEOUS THAT NO ONE IS DOING ANYTHING ABOUT IT. THE COMPANIES WHO RECOMMEND D THEIR PRODUCT BE FOR ORAL USE SHOULD BE STOPPED BECAUSE IT IS A DANGER TO BABIES. AS A MEDICAL PROFESSIONAL, I HAVE NEVER SEEN A SINGLE HOLE DEVICE PLACED IN ANY ORIFICE OF THE BODY FOR THE SIMPLE REASON THAT IT WILL GRAB THE SURROUNDING TISSUE WITH THE END RESULT BEING TRAUMA. DATE OF USE: 2000 -- 2008. DIAGNOSIS OR REASON FOR USE: SECRETION PRODUCTION FROM ENDOTRACHEAL TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BBG NONE JOL CHILDRENS MEDICAL VENTURES UNK
    2 LITTLE SUCKER ORAL NASAL SUCTION JOL NEOTECH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O