BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7-DAY LL VLV ADPT(STAND ALONE)

    MDR report key: 10145977 · Received June 11, 2020

    Report

    Report Number
    9616066-2020-01943
    Event Type
    Malfunction
    Date Received
    June 11, 2020
    Date of Event
    May 22, 2020
    Report Date
    May 22, 2020
    Manufacturer
    ISIA D.O.O. CAZIN
    Product Code
    FPA
    PMA / PMN Number
    K960280
    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 HAS ALSO STATED THAT THE CONNECTING PRODUCT WERE MANUFACTURED BY BAYER AND THAT THE RATE WAS 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 SMART SITE 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 SMART SITE® PRODUCT DEFECT. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 20 LL VLV ADPT(STAND ALONE) WERE CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TEAM ARE FACING PROBLEMS WHEN USING THIS MATERIAL ¿ REDUCED FLOW IN THE INFUSION PUMP WITH CONTRAST USE. CUSTOMER HAS SENT A VIDEO DEMONSTRATING THE TEST PERFORMED WITH SALINE SOLUTION 0,9% (BEFORE CONNECTION IN THE PATIENT). THE PROFESSIONALS REPORTED THERE IS NO PROPERLY FLOW AND THIS CAN BE VIEWED IN THE CHART AND PICTURES OF THE INJECTION PUMP. IT WAS ALSO REPORTED RESISTANCE DURING FLUSHING WITH SALINE SOLUTION 0,9%. IT WAS REPORTED THE USE OF EQUIPMENT LUER LOCK.

    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. 2000E7D/NO. 510K 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 2000E. THE 510K NUMBER PROVIDED IN IS FOR THE DOMESTIC SIMILAR PRODUCT.-K960280.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 20 LL VLV ADPT(STAND ALONE) WERE CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TEAM ARE FACING PROBLEMS WHEN USING THIS MATERIAL ¿ REDUCED FLOW IN THE INFUSION PUMP WITH CONTRAST USE. CUSTOMER HAS SENT A VIDEO DEMONSTRATING THE TEST PERFORMED WITH SALINE SOLUTION 0,9% (BEFORE CONNECTION IN THE PATIENT). THE PROFESSIONALS REPORTED THERE IS NO PROPERLY FLOW AND THIS CAN BE VIEWED IN THE CHART AND PICTURES OF THE INJECTION PUMP. IT WAS ALSO REPORTED RESISTANCE DURING FLUSHING WITH SALINE SOLUTION 0,9%. IT WAS REPORTED THE USE OF EQUIPMENT LUER LOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605852 7-DAY LL VLV ADPT(STAND ALONE) INTRAVASCULAR ADMINISTRATION SET FPA ISIA D.O.O. CAZIN 1012747

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200522| 20200522