BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL VLV ADPT(STAND ALONE)

    MDR report key: 10049913 · Received May 12, 2020

    Report

    Report Number
    9616066-2020-01520
    Event Type
    Malfunction
    Date Received
    May 12, 2020
    Date of Event
    April 7, 2020
    Report Date
    April 22, 2020
    Manufacturer
    CFN MEXICO 215 SA DE CV
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    2000E (B)(4) 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 IS FOR THE DOMESTIC SIMILAR PRODUCT.- K960280. INVESTIGATION SUMMARY: A 2000E PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 19066531. FURTHER INFORMATION FROM THE CUSTOMER CONFIRMED ONE OF THE CONNECTING PRODUCTS WAS A KANGKANG SYRINGE. ROOT CAUSE ANALYSIS: HERE¿¿S THE DHR FOR THE AFFECTED LOT NUMBER: PR: 360742, LOT: 19066531, MODEL 2000E (B)(4), QTY: (B)(4), QN/DEVIATION: NONE, MFG DATE: 20-JUN-2019. INVESTIGATION CONCLUSION: THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 19066531 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. THE ROOT CAUSE OF THE CUSTOMER¿¿S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER¿¿S EXPERIENCE. PLEASE NOTE THAT 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. IN THIS INSTANCE THE CONNECTING PRODUCT IN USE AT THE TIME OF THE CUSTOMER'S EXPERIENCE WAS NOT AVAILABLE FOR INVESTIGATION AND THEREFORE 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 ARE A SMALL NUMBER OF SIMILAR REPORTS; HOWEVER, THESE COMPLAINTS HAVE NOT BEEN ATTRIBUTABLE TO A SMARTSITE PRODUCT DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LL VLV ADPT(STAND ALONE) WAS OCCLUDED AND COULDN'T BE USED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON (B)(6) 2020, WHEN THE MAINTENANCE AND REPLACEMENT OF THE HEPARIN CAP WAS PRE-PUNCHED, IT WAS FOUND THAT NEW SMARTSITE WAS CLOSED AND COULD NOT BE USED. REPLACED ANOTHER CONNECTOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510521 LL VLV ADPT(STAND ALONE) INTRAVASCULAR ADMINISTRATION SET FPA CFN MEXICO 215 SA DE CV 2000E CHINA 19066531

    Patients

    Seq Age Sex Outcome Treatment
    1 Other