BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8699605 · Received June 14, 2019

    Report

    Report Number
    9610847-2019-00415
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    May 29, 2019
    Report Date
    August 1, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30382903851004
    PMA / PMN Number
    K013621
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD RECEIVED A Q-SYTE CLOSED LUER ACCESS DEVICE FROM LOT 8243562 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. A QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED NO PHYSICAL/MECHANICAL DAMAGE TO ANY OF THE COMPONENTS. NEXT, A FLOW RATE TEST WAS PERFORMED ON THE RETURNED UNIT AND WATER WAS SEEN FLOWING FREELY INTO AND OUT OF THE UNIT. THERE WERE NO OBSTRUCTIONS OBSERVED AND THE UNIT WAS FOUND TO BE WITHIN PRODUCT SPECIFICATIONS. BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. SINCE NO DEFECT WAS OBSERVED DURING INSPECTION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE CONNECTORS HAD OCCLUDED FLOW AFTER CONNECTING WITH THE TRANSFUSION SET FOR PRIMING, AND THE CONNECTORS WERE REPLACED AS A RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE NURSEHEAD NOTICED THAT THREE CONNECTORS WERE WITH FLOW OCCLUDED AFTER CONNECTED WITH THE TRANSFUSION SET FOR PRIMING. THE ISSUE WAS RESOLVED AFTER THE CONNECTORS WERE REPLACED"

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE CONNECTORS HAD OCCLUDED FLOW AFTER CONNECTING WITH THE TRANSFUSION SET FOR PRIMING, AND THE CONNECTORS WERE REPLACED AS A RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE HEAD NURSE NOTICED THAT THREE CONNECTORS WERE WITH FLOW OCCLUDED AFTER CONNECTED WITH THE TRANSFUSION SET FOR PRIMING. THE ISSUE WAS RESOLVED AFTER THE CONNECTORS WERE REPLACED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495603 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8243562 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other