BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGEBORE 8 INCH EXT VLV

    MDR report key: 10547864 · Received September 17, 2020

    Report

    Report Number
    9616066-2020-02802
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Date of Event
    August 27, 2020
    Report Date
    August 27, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.
    Product Code
    FPA
    UDI-DI
    07613203012317
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT THAT ONE SET OF TUBING WAS DIFFICULT TO FLUSH AND THE OTHER ONE WAS OCCLUDED COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW FOR MODEL 20059E LOT NUMBER 20076814 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF 8803 UNITS IN 1 LOT NUMBER WAS BUILT ON 29JUL2020 THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: NO PRODUCT WILL BE RETURNED PER CUSTOMER. NO INVESTIGATION WAS PERFORMED. ROOT CAUSE DESCRIPTION: DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LARGEBORE 8 INCH EXT VLV WAS CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE OR DIRECTOR HAS GIVEN ME AN ITEM THAT THEY¿VE BEEN HAVING AN ISSUE WITH. REF# (B)(4). SMARTSITE EXTENSION SET. THEY DIDN¿T START SAVING THE PACKAGING UNTIL THESE LAST TWO. THEY ARE TELLING ME THEY HAVE A HARD TIME FLUSHING THROUGH IT. THE ONE NURSE HAD TO USE ¿ALMOST HER WHOLE BODY WEIGHT¿ JUST TO GET THE FLUID THROUGH. ANOTHER ONE CAME BACK SAYING ¿OCCLUDED¿. CUSTOMER RESPONSE (B)(6) 2020: I DON¿T HAVE THE ITEM, ONLY THE OUTER PLASTIC THAT GIVES THE LOT AND EXPIRATION INFO. DATE OF INCIDENT: UNKNOWN, DATE REPORTED: (B)(6) 2020, PART NAME: SMARTSITE¿ EXTENSION SETS, ITEM NO: 20059E. THE EXTENSION TUBING IS PRIMED TO THE IV BAG AND TUBING PRIOR TO BEING ATTACHED TO THE PATIENT¿S IV. THE FAULTY EXTENSION TUBING IS CAUGHT AT THAT TIME. HAS OCCURRED ABOUT 12 TIMES TO SEVERAL DIFFERENT NURSES. NO PATIENT INFORMATION AT THIS TIME. THE ADDITIONAL LOT IS 20076814.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010258 LARGEBORE 8 INCH EXT VLV INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. 20076814 07613203012317

    Patients

    Seq Age Sex Outcome Treatment
    1 Other