BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16199803 · Received January 18, 2023

    Report

    Report Number
    9610847-2022-00521
    Event Type
    Malfunction
    Date Received
    January 18, 2023
    Date of Event
    September 1, 2022
    Report Date
    February 27, 2023
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    00382903851003
    PMA / PMN Number
    K142527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1243420. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE LEAKED AT THE LUER CONNECTION, AND CRACKS WERE FOUND AFTER INSPECTING THE AREA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "THE PATIENT'S PICC CIRCUIT HAS BEEN PLACED. DURING USE, IT WAS FOUND THAT THERE WAS WATER IN THE CONNECTOR. AFTER WIPING IT WITH A PAPER TOWEL, NO OBVIOUS LEAKAGE OF LIQUID WAS FOUND. HOWEVER, AFTER 20 MINUTES, THE NURSE CONTINUED TO FIND THE LEAKAGE, AND IT STOPPED LEAKING AFTER REPLACING THE NEW CONNECTOR. CAREFUL INSPECTION OF THE REPLACED JOINTS REVEALED CRACKS LEADING TO LEAKS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE LEAKED AT THE LUER CONNECTION, AND CRACKS WERE FOUND AFTER INSPECTING THE AREA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "THE PATIENT'S PICC CIRCUIT HAS BEEN PLACED. DURING USE, IT WAS FOUND THAT THERE WAS WATER IN THE CONNECTOR. AFTER WIPING IT WITH A PAPER TOWEL, NO OBVIOUS LEAKAGE OF LIQUID WAS FOUND. HOWEVER, AFTER 20 MINUTES, THE NURSE CONTINUED TO FIND THE LEAKAGE, AND IT STOPPED LEAKING AFTER REPLACING THE NEW CONNECTOR. CAREFUL INSPECTION OF THE REPLACED JOINTS REVEALED CRACKS LEADING TO LEAKS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069001 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 1243420 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown