BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8667340 · Received June 4, 2019

    Report

    Report Number
    9610847-2019-00399
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 20, 2019
    Report Date
    July 15, 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

    INVESTIGATION SUMMARY: BD RECEIVED A Q-SYTE CLOSED LUER SET FROM LOT 6181551 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED NO PHYSICAL/MECHANICAL DAMAGE. NEXT, A WATER/AIR LEAK TEST WAS PERFORMED AND NO LEAKAGE WAS OBSERVED IN THE ACTUATED OR UNACTUATED POSITION. BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. SINCE NO DAMAGE OR LEAKAGE WAS OBSERVED THE ENGINEER WAS UNABLE TO IDENTIFY THE DEFINITIVE ROOT CAUSE. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS LEAKAGE AT THE LUER CONNECTION WITH A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE. THIS OCCURRED ON3 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: IT'S FOUND THAT THREE Q-SYTE CONNECTORS LEAKED AT THE MALE LUER CONNECTION ON THE SECOND/THIRD DAY OF PLACEMENT; WHICH WERE FROM THE SAME LOT.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 THERE WAS LEAKAGE AT THE LUER CONNECTION WITH A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE. THIS OCCURRED ON 3 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: IT'S FOUND THAT THREE Q-SYTE CONNECTORS LEAKED AT THE MALE LUER CONNECTION ON THE SECOND/THIRD DAY OF PLACEMENT; WHICH WERE FROM THE SAME LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458712 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 6181551 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other