BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO INTERVENTIONAL PACK (NITAE)809

    MDR report key: 10899856 · Received November 25, 2020

    Report

    Report Number
    1423537-2020-00568
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    October 26, 2020
    Report Date
    November 24, 2020
    Manufacturer
    MEX03 MEXICO-JUAREZ PRESOURCE
    Product Code
    OJG
    UDI-DI
    10888439877175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT NUMBER 20200525-23-SH REVEALED THE PRODUCT WAS MANUFACTURED ON MAY 31ST 2020. BASED ON SUPPLIER INVESTIGATION, THE DEVICE HISTORY RECORD REVIEW DID NOT INDICATE ANY EXCEPTION THAT COULD LEAD TO THE REPORTED INCIDENT. THE AVERAGE LINTING DATA IS 0.143G / 10PIECES. NO SAMPLE WAS RETURNED FOR INVESTIGATION, ONLY PHOTOS WERE PROVIDED. NO OBVIOUS ABNORMAL LINT WAS FOUND ON THE SURFACE OF THE PRODUCT; HOWEVER, THERE ARE NEPS ON THE SURFACE OF THE TOWEL. ACCORDING TO THE SUPPLIER, OR TOWEL IS MADE OF COTTON, SO COTTON FIBER IS BORN. THE SUPPLIER IS CONTINUOUSLY WORKING WITH CARDINAL HEALTH TO BETTER CONTROL THE LINTING AND HAVE IMPLEMENTED SEVERAL MEASURES TO IMPROVE IT: SUCTIONS MACHINES HAVE BEEN INSTALLED IN GREY CLOTH ROLLING PROCESS, DYEING PROCESS AND CUTTING PROCESS. THE SUCTION PROCESS WAS ADDED BEFORE PRODUCT'S FINAL FOLDING, AND WORKERS DO IT ACCORDING TO STANDARD OPERATION PROCEDURE REQUIREMENT. C. LINTING TEST METHOD AND ACCEPTABLE CRITERIA WAS STIPULATED TO SEE THE SUCTION RESULTS. (=0.38G/10PIECES). IN THE FOLDING PROCESS, SUPPLIER USED ONE CLOTH PAD UNDER 100PIECES SEMI-FINISHED PRODUCTS TO AVOID LINTING STUCK ONTO THE PRODUCTS DURING PRODUCT'S TRANSFER. THE INVESTIGATION REVEALED NO ABNORMAL SITUATION HAPPENED IN PRODUCTION; THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT INFORMATION WAS SHARED WITH THE RELEVANT SECTORS FOR THEIR AWARENESS. NO ACTION WILL BE TAKEN AT THIS TIME, BUT THE SUPPLIER WILL CONTINUE TO MONITOR THE TRENDS FOR THIS TYPE OF INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED EXCESSIVE LINTING OF BLUE COTTON TOWEL IN THE PACK FOUND DURING CEREBRAL ANGIOGRAM WITH INTERVENTION. THERE WAS NO INJURY OR ADVERSE EFFECT DUE TO EXCESSIVE LINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364328 NEURO INTERVENTIONAL PACK (NITAE)809 NEUROLOGICAL TRAY OJG MEX03 MEXICO-JUAREZ PRESOURCE SNE73NITA6 474827 10888439877175

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR