BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA 20GA 1.75IN HF Y

    MDR report key: 12508237 · Received September 21, 2021

    Report

    Report Number
    1710034-2021-00833
    Event Type
    Malfunction
    Date Received
    September 21, 2021
    Date of Event
    August 25, 2021
    Report Date
    October 7, 2021
    Product Code
    FOZ
    UDI-DI
    00382903835386
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLES AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED THIRTY-ONE UNITS AND THREE PHOTOS. THROUGH THE VISUAL EXAMINATION, IT WAS OBSERVED THAT ALL 31 RETURNED UNITS HAD VARYING LEVELS OF THE DEFORMATION OF THE BOTTOM WEB. THE REPORTED DEFECT WAS CONFIRMED. ADDITIONALLY, 11 OF THE UNITS WERE FOUND TO HAVE AN OPENING IN THE SEAL. MOST OF THE 11 OPENED UNITS HAD THE HIGHEST DEGREE OF WARPING OF ALL THE UNITS, LIKELY INDICATING THAT THE WARPING ITSELF CAUSED THE SEAL TO BE BROKEN. FURTHER INSPECTION OF THE OPENED UNITS FOUND THAT THE SEAL ADHESIVE WAS PRESENT AND WAS UNIFORM ON THE BOTTOM WEB, INDICATING THAT UNIT HAD BEEN FULLY SEALED BEFORE THE SEAL WAS BROKEN. THE OBSERVED DEFORMED/SHRUNK PACKAGES ARE MOST COMMONLY A RESULT OF EXPOSURE TO EXTREME HEAT AND THEREFORE ARE MOST LIKELY DUE TO TRANSIT OR STORAGE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEXIVA 20GA 1.75IN HF Y NEEDLE WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A DELIVERY OF SOME DEFECTIVE PRODUCTS. THE ENTIRE BOX FROM THIS DELIVERY IS UNUSABLE AND I ALSO HAVE 10 EACH FROM AN EARLIER DELIVERY, BUT NOT SURE WHAT PO IT WOULD HAVE BEEN ON. NOT SURE IF IT¿S ENTIRELY CLEAR FROM THE PHOTOS BUT THE PACKAGING APPEARS TO HAVE BEEN MELTED AND IN A NUMBER OF CASES HAS SPLIT OPEN DUE TO WARPING.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEXIVA 20GA 1.75IN HF Y NEEDLE WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A DELIVERY OF SOME DEFECTIVE PRODUCTS. THE ENTIRE BOX FROM THIS DELIVERY IS UNUSABLE AND I ALSO HAVE 10 EACH FROM AN EARLIER DELIVERY, BUT NOT SURE WHAT PO IT WOULD HAVE BEEN ON. NOT SURE IF IT¿S ENTIRELY CLEAR FROM THE PHOTOS BUT THE PACKAGING APPEARS TO HAVE BEEN MELTED AND IN A NUMBER OF CASES HAS SPLIT OPEN DUE TO WARPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1404878 NEXIVA 20GA 1.75IN HF Y INTRAVASCULAR CATHETER FOZ 0274618 00382903835386

    Patients

    Seq Age Sex Outcome Treatment
    1