BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL VLV ADPT(STAND ALONE)

    MDR report key: 10574527 · Received September 23, 2020

    Report

    Report Number
    9616066-2020-02858
    Event Type
    Malfunction
    Date Received
    September 23, 2020
    Date of Event
    August 25, 2020
    Report Date
    August 31, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A 2000E CHINA PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER, THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 19075408. NO FURTHER INFORMATION WAS AVAILABLE TO ASSIST THE INVESTIGATION IN THIS INSTANCE. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 19075408 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. IT WAS NOT POSSIBLE TO CONFIRM THE ROOT CAUSE OF THE REPORTED ISSUE IN THIS INSTANCE. PREVIOUS COMPLAINTS FOR OCCLUSIONS HAVE BEEN RELATED TO FEATURES ON THE SURFACE OF THE MALE LUER OF THE CONNECTING PRODUCTS. THESE FEATURES INCLUDE FLASH OR A RAISED EDGE TO THE TIP OF THE MALE LUER WHICH HAVE PREVIOUSLY BEEN SHOWN TO INTERMITTENTLY LEAD TO RESTRICTED FLOW DUE TO THEM PINCHING THE BLUE PISTON OF THE SMARTSITE AND NOT ALLOWING IT TO OPEN. THIS CAN SOMETIMES BE RESOLVED BY DISCONNECTING AND REATTACHING THE SAME LUER CONNECTION WHICH MAY REPOSITION THE LUER AGAINST THE PISTON AND IMPROVE THE FLOW, OR ALTERNATIVELY BY CHANGING THE CONNECTING MALE LUER. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THERE ARE A SMALL NUMBER OF SIMILAR REPORTS; HOWEVER, THESE COMPLAINTS HAVE NOT BEEN ATTRIBUTABLE TO A SMARTSITE PRODUCT DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LL VLV ADPT(STAND ALONE) WAS CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE GAVE INJECTION TO THE PATIENT, AND THE INFUSION CONNECTOR WAS CONNECTED TO THE SYRINGE NEEDLE AND THE BOLUS WAS NOT UNBLOCKED AND THEN THE INFUSION CONNECTOR WAS REPLACED.

    Additional Manufacturer Narrative · 1

    2000E (B)(4) THIS IS AN INTERNATIONAL CODE- THE MODEL#/CATALOG# IDENTIFIED IS A CAREFUSION PRODUCT WHICH IS SAME OR SIMILAR TO A DEVICE THAT IS APPROVED FOR SALE DOMESTICALLY. THE DOMESTIC SIMILAR LIST NUMBER IS MZ1000-07. THE 510K NUMBER PROVIDED IS FOR THE DOMESTIC SIMILAR PRODUCT.-K960280. 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 THE LL VLV ADPT(STAND ALONE) WAS CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE GAVE INJECTION TO THE PATIENT, AND THE INFUSION CONNECTOR WAS CONNECTED TO THE SYRINGE NEEDLE AND THE BOLUS WAS NOT UNBLOCKED AND THEN THE INFUSION CONNECTOR WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036633 LL VLV ADPT(STAND ALONE) INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 19075408

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200825| 20200825