BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD CONNECTA¿ STOPCOCKS

    MDR report key: 5762419 · Received June 30, 2016

    Report

    Report Number
    9610847-2016-00021
    Event Type
    Injury
    Date Received
    June 30, 2016
    Date of Event
    June 12, 2016
    Report Date
    July 18, 2016
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    K974083
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURER 6/15/2016. PMA / 510(K) #: K974083.

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6007610. A MANUFACTURING REVIEW REVEALED NO ISSUES WITH THE MANUFACTURING PROCESS, MAINTENANCE OR CALIBRATED INSTRUMENTS. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    THE SUSPECT DEVICE DISCONNECTED AT THE LUER CONNECTION TO CENTRAL LINE. AT THE TIME, OLICLINOMEL N7, G5 (500ML), POTASSIUM, CERNEVIT, NUTRYELT WAS INFUSING THROUGH THE LINE AS WELL AS MORPHINE RUNNING CONTINUOUSLY BY PUMP SYRINGE. THE PATIENT THEN STARTED TO FEEL "UNWELL." AT DISCONNECTION, AIR ENTERED THE IV LINE(ABOUT 30CM) BUT NOT INTO THE CENTRAL LINE. CLINICAL CONSEQUENCES OBSERVED: BLOOD PRESSURE DECREASED SIGNIFICANTLY, OXYGEN SATURATION WAS AT 84% AND THE PATIENT HAD NO PULSE FOR 20 SECONDS. AS A RESULT, MEDICAL INTERVENTIONS WERE TAKEN DIRECTLY AFTER STOPCOCK DETACHMENT WHICH INCLUDE: RESTORATION IN CONTINUITY OF THE INFUSION LINE, BLOOD VOLUME EXPANSION AND OXYGEN THERAPY FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418123 BD CONNECTA¿ STOPCOCKS STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 6007610

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention