BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10446053 · Received August 24, 2020

    Report

    Report Number
    9610847-2020-00257
    Event Type
    Malfunction
    Date Received
    August 24, 2020
    Date of Event
    July 2, 2020
    Report Date
    September 8, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30382903851004
    PMA / PMN Number
    K013621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. THE DHR FOR SUBLOTS 9092711, 9092712 AND 9088726 WAS REVIEWED. 9092712 HAD ONE RELATED QN FOUND, 200808587. THE OTHER SUBLOTS HAD NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS FOUND. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE AT LUER CONNECTION OCCURRED DURING USE WITH A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON THE AFTERNOON OF (B)(6) 2020, THE PATIENT WAS TREATED WITH THE SEPARABLE MEMBRANE NEEDLE-FREE CLOSED INFUSION CONNECTOR FOR INFUSION. AT 17:00, THE NURSE FOUND THAT THE SEPARABLE MEMBRANE INFUSION CONNECTOR LEAKING. AFTER CHECKING THAT THE INTERFACE WAS TIGHTLY CONNECTED AND NOT LOOSE, IMMEDIATELY REPLACEMENT OF A NEW SEPARABLE MEMBRANE NEEDLELESS CLOSED INFUSION CONNECTOR FOR PATIENTS TO USE, WITHOUT AFFECTING THE PATIENT'S CONDITION.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE AT LUER CONNECTION OCCURRED DURING USE WITH A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: ON THE AFTERNOON OF (B)(6) 2020, THE PATIENT WAS TREATED WITH THE SEPARABLE MEMBRANE NEEDLE-FREE CLOSED INFUSION CONNECTOR FOR INFUSION. AT 17:00, THE NURSE FOUND THAT THE SEPARABLE MEMBRANE INFUSION CONNECTOR LEAKING. AFTER CHECKING THAT THE INTERFACE WAS TIGHTLY CONNECTED AND NOT LOOSE, IMMEDIATELY REPLACEMENT OF A NEW SEPARABLE MEMBRANE NEEDLELESS CLOSED INFUSION CONNECTOR FOR PATIENTS TO USE, WITHOUT AFFECTING THE PATIENT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911021 BD Q-SYTE LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 385100 9122580 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other