BEUDAMED
    FDA Adverse Event Death Summary report: N

    BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

    MDR report key: 6390346 · Received March 8, 2017

    Report

    Report Number
    9610847-2017-00013
    Event Type
    Death
    Date Received
    March 8, 2017
    Date of Event
    February 11, 2017
    Report Date
    February 22, 2017
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    PMA / PMN Number
    K013621
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: RESULT - (B)(4) RECEIVED ONE Q-SYTE UNIT WITHOUT PACKAGING. THE UNIT WAS IN 2 PORTIONS: PORTION 1; THE TOP BODY/SEPTUM OF THE Q-SYTE AND PORTION 2; THE BOTTOM BODY OF THE Q-SYTE UNIT. A VISUAL/MICROSCOPIC EVALUATION WAS PERFORMED. TRACES OF A WELD FLASH ON THE RIMS OF THE TOP AND BOTTOM BODY WERE OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 6153901. CONCLUSION - THE DEFECTS LEAKAGE AND WELD JOINT SEPARATION WERE CONFIRMED. THE TOP AND BOTTOM BODY WERE SEPARATED AT THE WELD JOINT LOCATION WHICH CREATED A PATH FOR LEAKAGE. BD IS UNABLE TO CONFIRM THE PATIENT DEATH. A DEFINITE SOURCE THAT CONTRIBUTED TO THE SEPARATION AT THE WELD JOINT LOCATION COULD NOT BE ESTABLISHED. ALTHOUGH AN INADEQUATE WELD FLASH WAS OBSERVED; THE Q-SYTE UNIT WAS IN USE FOR TWO DAYS BEFORE THE SEPARATION OCCURRED. THIS PROVIDES EVIDENCE THAT THERE WAS AN ADEQUATE WELD BETWEEN Q-SYTE TOP AND BOTTOM BODIES PROVIDED DURING THE MANUFACTURING PROCESS. THE WELD JOINT SEPARATION COULD HAVE BEEN INTRODUCED BY EXTERNAL FORCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT 1500 ON (B)(6) 2017, THE PATIENT WAS RECEIVING A LOWER LIMB INFUSION. THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE WAS BEING USED WITH AN UNKNOWN NON-BD BRAND STI AND INFUSION SET. THE NURSE FOUND THE SUSPECT DEVICE BROKEN AT 1830 ON (B)(6) 2017 AND NOTED BLOOD AND MEDICATION HAD LEAKED FROM THE CONNECTOR. THE MEDICATION BEING INFUSED WAS METHYLPREDNISOLONE, MUCOSOLVAN, AND AVELOX DISSOLVED IN 5% GLUCOSE SALINE. THE MIDDLE PART OF THE SUSPECT DEVICE WAS FOUND BROKEN IN TWO SECTION. A NEW Q-SYTE WAS IMMEDIATELY REPLACED AND THE INFUSION WAS CONTINUED. AT THIS TIME, THE PATIENT'S BLOOD RESULTS WERE NORMAL, VITAL SIGNS STEADY, AND THE DOCTOR ESTIMATED THE BLOOD LOSS TO BE ABOUT 30 ML. THE PATIENT DIED ON (B)(6) 2017. THE PATIENT WAS INITIALLY HOSPITALIZED FOR COPD BUT WAS NOT CRITICALLY ILL. PER REPORT ON (B)(6) 2017, "AT PRESENT, THE HOSPITAL DID NOT IDENTIFY THE FINAL DEATH OF PATIENTS BUT THE HOSPITAL MAY BE CONSIDERED AS A CAUSE OF CARDIAC DISEASE." NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170985 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE LUER ACCESS SPLIT-SEPTUM FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 6153901

    Patients

    Seq Age Sex Outcome Treatment
    1 Death