BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7-DAY LL VLV ADPT(STAND ALONE)

    MDR report key: 10146111 · Received June 11, 2020

    Report

    Report Number
    9616066-2020-01920
    Event Type
    Malfunction
    Date Received
    June 11, 2020
    Date of Event
    May 19, 2020
    Report Date
    May 19, 2020
    Manufacturer
    ISIA D.O.O. CAZIN
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES WERE RECEIVED FOR INVESTIGATION OF COMPLAINT REFERENCE (B)(4); HOWEVER THE CUSTOMER HAS INDICATED THAT THEY HAVE EXPERIENCED OCCLUSIONS WHEN USING THE 2000E7D PRODUCT FROM LOT 1012747. THE CUSTOMER STATED THAT THE CONNECTING PRODUCTS WERE MANUFACTURED BY BAYER AND THAT CONTRAST WAS INJECTED AT A RATE OF 3ML/S. THE CUSTOMER ALSO PROVIDED VIDEOS WHICH SHOWED THE PRODUCT IN USE WITH AN EXTENSION SET; ANALYSIS OF THE VIDEO NOTED THAT FLOW WAS POSSIBLE ALTHOUGH IT WAS NOT POSSIBLE TO VERIFY THE FLOW RATE. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED IN THIS INSTANCE AS NO SAMPLES WERE RECEIVED FOR INVESTIGATION. WITHOUT A SAMPLE TO EXAMINE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE; HOWEVER, A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1012747 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. IN THIS INSTANCE, A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER'S EXPERIENCE COULD NOT BE DETERMINED; HOWEVER PREVIOUS REPORTS OF A SIMILAR NATURE HAVE BEEN FOUND TO BE RELATED TO FEATURES ON THE SURFACE OF THE MALE LUER OF THE CONNECTING PRODUCT. THESE FEATURES, INCLUDING FLASH OR A RAISED EDGE TO THE TIP OF THE MALE LUER, HAVE PREVIOUSLY BEEN SHOWN TO LEAD TO INTERMITTENT 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. HOWEVER AS NEITHER THE 2000E7D NOR THE CONNECTING PRODUCT IN CLINICAL USE AT THE TIME OF THE CUSTOMER'S EXPERIENCE WERE RECEIVED FOR INVESTIGATION, IT HAS NOT BEEN POSSIBLE TO CONFIRM IF THIS MAY HAVE CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THERE HAVE BEEN A SMALL NUMBER OF SIMILAR REPORTS RECEIVED IN THE LAST TWELVE MONTHS; HOWEVER, TO DATE THESE COMPLAINTS HAVE NOT BEEN ATTRIBUTABLE TO A SMARTSITE® PRODUCT DEFECT. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 7-DAY LL VLV ADPT(STAND ALONE) WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TEAM ARE FACING PROBLEMS WHEN USING THIS MATERIAL. THE REPORTED FEEDBACK SUGGESTS THAT THERE IS CONNECTOR FAILURE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 7-DAY LL VLV ADPT (STAND ALONE) WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TEAM ARE FACING PROBLEMS WHEN USING THIS MATERIAL. THE REPORTED FEEDBACK SUGGESTS THAT THERE IS CONNECTOR FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610010 7-DAY LL VLV ADPT(STAND ALONE) VALVE FPA ISIA D.O.O. CAZIN 1012747

    Patients

    Seq Age Sex Outcome Treatment
    1 Other