BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART CATH PACK (HCNSB)177

    MDR report key: 14842637 · Received June 28, 2022

    Report

    Report Number
    1423537-2022-00794
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    June 7, 2022
    Report Date
    June 28, 2022
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    OEQ
    UDI-DI
    10888439824247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON SUPPLIER INVESTIGATION, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS LOT NUMBER WAS NOT PROVIDED. SUPPLIER RECORDS WERE REVIEWED, AND NO ABNORMALITIES WERE FOUND. THERE WAS NO SAMPLE AVAILABLE FOR INVESTIGATION. ACCORDING TO 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. 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 COMPLAINT INFORMATION WAS SHARED WITH THE RELEVANT SECTORS FOR THEIR AWARENESS. NO ACTION WILL BE TAKEN AT THIS TIME. THE SUPPLIER WILL CONTINUE TO MONITOR TRENDS FOR THIS TYPE OF INCIDENT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED AN ABUNDANCE OF SHEDDING OF THE BLUE COTTON OR TOWELS, PWTB04-STM, FROM THE HEART CATH PACK, SAN21HCNSC. NO INJURY WAS REPORTED. NO FURTHER INFORMATION, CLINICAL DATA, OR PATIENT DEMOGRAPHICS WERE PROVIDED WHEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704477 HEART CATH PACK (HCNSB)177 ANGIOGRAPHY/ANGIOPLASTY KIT OEQ CARDINAL HEALTH 200, LLC SAN21HCNSC UNKNOWN 10888439824247

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown