BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC CATH PACK (CCHKE)819

    MDR report key: 10962807 · Received December 7, 2020

    Report

    Report Number
    1423537-2020-00575
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Date of Event
    November 11, 2020
    Report Date
    December 7, 2020
    Manufacturer
    MEX03 MEXICO-JUAREZ PRESOURCE
    Product Code
    OEQ
    UDI-DI
    10887488627731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE DEVICE HISTORY RECORD, LOT# 20191101-23-SH WAS FINISHED ON 04TH NOV 2019. BASED ON SUPPLIER INVESTIGATION, DEVICE HISTORY RECORD (DHR) REVIEW DID NOT INDICATE ANY EXCEPTION THAT COULD LEAD TO THE REPORTED INCIDENT. THE AVERAGE LINTING DATA IS 0.175G / 10 PIECES. THERE ARE 166 OCCURRENCES REPORTED IN THE PAST 12 MONTHS. NO SAMPLE WAS RETURNED FOR INVESTIGATION, ONLY PHOTOS WERE PROVIDED. FROM THE PHOTOS THERE IS A NEP SEEN ON THE SURFACE OF THE TOWEL. ACCORDING TO SUPPLIER, OR TOWEL IS MADE OF COTTON, SO COTTON FIBER IS BORN. 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. LINTING TEST METHOD AND ACCEPTABLE CRITERIA WAS STIPULATED TO SEE THE SUCTION RESULTS. (B)(4). IN THE FOLDING PROCESS, SUPPLIER USED ONE CLOTH PAD UNDER 100 PIECES SEMI-FINISHED PRODUCTS TO AVOID LINTING STUCK ONTO THE PRODUCTS DURING PRODUCT'S TRANSFER. FROM THE INVESTIGATION, NO ABNORMAL SITUATION HAPPENED IN PRODUCTION OR DHR. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT INFORMATION WAS INFORMED TO THE RELEVANT SECTORS FOR THEIR AWARENESS. THERE IS NO ACTION TAKEN AT THIS TIME, BUT SUPPLIER WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED LINT AND FUZZ COMING FROM THE STERILE TOWELS PWTB04-STM FROM THE CARDIAC CATHETERIZATION PACK SAN41CCHKE DURING AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) PROCEDURE . LINT WAS FOUND ON THE WIRES AND BALLOONS DURING THE PROCEDURE. PIECES WERE REMOVED WITH IRRIGATION AND MANUAL REMOVAL. NO INJURY OCCURRED. NO PATIENT DEMOGRAPHICS WERE PROVIDED UPON REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427719 CARDIAC CATH PACK (CCHKE)819 ANGIOGRAPHY/ANGIOPLASTY KIT OEQ MEX03 MEXICO-JUAREZ PRESOURCE SAN41CCHKE 488522 10887488627731

    Patients

    Seq Age Sex Outcome Treatment
    1 Other