BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTECH RAM CANNULA

    MDR report key: 3736051 · Received March 31, 2014

    Report

    Report Number
    2025917-2014-00007
    Event Type
    Injury
    Date Received
    March 31, 2014
    Date of Event
    August 1, 2013
    Report Date
    February 10, 2014
    Manufacturer
    NEOTECH PRODUCTS, INC.
    Product Code
    CAT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    : THERE WERE MULTIPLE INCIDENTS OF A SIMILAR NATURE, BUT NONE WERE EVER FORMALLY DOCUMENTED BY THE FACILITY. THE FACILITY DID PROVIDE SEVERAL LOT NUMBERS FROM ORDERS THAT THEY HAD PLACED OVER THE LAST SEVERAL MONTHS, BUT WERE UNABLE TO DETERMINE ANY SPECIFIC LOT NUMBER(S) BELIEVED TO BE THE CAUSE OF THE EVENTS. WITHOUT A SPECIFIC LOT NUMBER, WE ARE UNABLE TO DETERMINE A DATE OF MFR. PER A CONVERSATION WITH FDA EMPLOYEE, (B)(4), ON (B)(4) 2014, ONLY THIS REPORT WILL BE SUBMITTED ALTHOUGH WE ARE AWARE THAT THERE WERE MULTIPLE INCIDENTS. DUE TO THE FACT THAT THERE IS NO CLEAR DATA REGARDING EVENT DATES OR DEVICE/PATIENT INFO, AS WELL AS THE FACT THAT THE COMPLAINANT'S REMARK THAT THERE WERE "ABOUT 30" INCIDENTS WAS "JUST A GUESS", WE FEEL THAT ONE REPORT SHOULD BE APPROPRIATE IN THIS SITUATION. IT WAS DETERMINED BASED ON THE INFO THAT THE COMPLAINANT PROVIDED THAT THE LIKELY CAUSE OF THE EVENTS WAS THE FAILURE OF THE STAFF TO PROPERLY FOLLOW THE DEVICE'S DIRECTIONS FOR USE AND PERHAPS ALSO THE METHOD USED TO SECURE THE CANNULA TO THE FACE, AS APPARENTLY IT "HAS ALWAYS BEEN AN ISSUE." SINCE REMINDING THE COMPLAINANT THAT THE CANNULA SHOULD BE PROPERLY SECURED TO THE FACE & THAT THE NARES SHOULD NOT BE TOTALLY OCCLUDED, AS WELL AS SENDING CANNULA HOLDER SAMPLES TO THE FACILITY, NO FURTHER SITUATION AND THE HOSPITAL STAFF IS ENCOURAGED TO MAKE US AWARE SHOULD THE PROBLEM(S) CONTINUE. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE NASAL OXYGEN CANNULA WAS "COMING OUT OF THE NARES & NOT STAYING ON THE FACE." WHEN ASKED HOW MANY TIMES THIS HAD HAPPENED, THE COMPLAINANT RESPONDED, "ABOUT THIRTY, BUT THAT'S JUST A GUESS." WHEN THIS HAD OCCURRED IN THE PAST, THE COMPLAINANT STATED THAT IT HAD CAUSED SEVERAL PATIENTS TO BECOME "HYPOXIC & DESAT.' WHEN ASKED HOW THE CANNULA WAS BEING USED, IT WAS LEARNED THAT THE STAFF BEGAN USING LARGER CANNULAS TO PREVENT THE PRONGS FROM COMING OUT OF THE NARES, HOWEVER, WHEN THE LARGER CANNULAS WERE USED, THE STAFF BEGAN TO NOTICE REDNESS AROUND THE SEPTUM, SO THEY BEGAN USING CANNULAIDE & SWITCHED BACK TO THE SMALLER CANNULAS. THE STAFF TREATED THE REDNESS WITH DUODERM BETWEEN THE NARES. ALTHOUGH NO PATIENTS WERE SERIOUSLY INJURED, & THE COMPLAINANT ASSURED THAT THERE IS ALWAYS A STAFF MEMBER NEARBY THESE PATIENTS, HE EXPRESSED CONCERN ABOUT SEPTAL EROSION/PRESSURES SORES IF THE PROBLEM CONTINUES. THE COMPLAINANT STATED THAT THE PATIENTS ARE BEING REPOSITIONED MORE OFTEN THAN THEY WERE IN THE PAST, SO HE FELT THAT THIS MAY HAVE SOMETHING TO DO WITH THE CANNULAS FALLING OUT MORE OFTEN THAN BEFORE, ALTHOUGH IT SEEMED TO HIM THAT IT HAPPENS "MORE WHILE THE BABIES ARE IN THE PRONE POSITION." THE STAFF BEGAN TO NOTICE THE PROBLEM "APPROX. 6 MONTHS PRIOR", YET NEVER MADE THE MFR AWARE & NEVER FORMALLY DOCUMENTED ANY OF THESE EVENTS AT THE FACILITY, THEREFORE, THE COMPLAINANT STATED THAT HE NEVER FORMALLY DOCUMENTED ANY OF THESE EVENTS AT THE FACILITY, THEREFORE, THE COMPLAINANT STATED THAT HE WAS UNABLE TO PROVIDE ANY FURTHER INFO ABOUT THE EVENTS OR ANY SPECIFICS ABOUT ANY OF THE PTS INVOLVED. HE DID STATE THAT SECURING THE CANNULAS "HAS ALWAYS BEEN AN ISSUE." WE REMINDED THE PATIENTS INVOLVED. HE DID STATE THAT SECURING THE CANNULAS "HAS ALWAYS BEEN AN ISSUE." WE REMINDED THE COMPLAINANT THAT THE CANNULA'S DIRECTIONS FOR USE STATED THAT THE NARES SHOULD NOT BE COMPLETELY OCCLUDED, THEREFORE, THEY SHOULD NOT BE USING CANNULAIDE, & THAT THE CANNULA SHOULD BE SECURED TO THE FACE. THE FACILITY WAS SENT SAMPLES OF OUR TUBING & CANNULA HOLDERS TO TRY. AS OF THE DATE OF THIS SUBMISSION, WE HAVE NOT RECEIVED ANY FURTHER COMPLAINTS OF THIS NATURE FROM THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189906 NEOTECH RAM CANNULA NASAL OXYGEN CANNULA CAT NEOTECH PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention