BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPID ASSAY PIFA HEPARIN PLATELET FACT4

    MDR report key: 10691976 · Received October 16, 2020

    Report

    Report Number
    1423537-2020-00545
    Event Type
    Injury
    Date Received
    October 16, 2020
    Date of Event
    September 17, 2018
    Report Date
    November 5, 2020
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    LCO
    UDI-DI
    00708872615123
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT CODE 4036025A, RAPID ASSAY PIFA HEPARIN PLATELET FACT4, MANUFACTURED BY AKERS BIOSCIENCES INC., MANUFACTURER NUMBER 4036025, SHIPPED TO OUR CARDINAL HEALTH FACILITY BETWEEN 1/1/18 THRU 8/30/2020. UPON RECEIPT, PRODUCTS WERE REMOVED FROM DELIVERY TRAILERS WITHIN THE REQUIRED TIMEFRAME PER CARDINAL HEALTH POLICY AND PLACED INTO REFRIGERATED STORAGE PER LABELED PRODUCT STORAGE CONDITIONS. CARDINAL HEALTH SHIPPED TWO ORDERS TO THE HOSPITAL DURING THIS TIME. THE PRODUCTS WERE PACKED IN BOXES WITH FOAM AND THE PRODUCT IS WRAPPED IN PLASTIC WITH ICE ON TOP AND BOTTOM PER CARDINAL HEALTH POLICY AND AS DIRECTED BY THE MANUFACTURER. AS PART OF THE SHIPPING PROCESS, CARDINAL HEALTH STAMPS THE PAPERWORK WITH THE TIME AND DATE OF PACKING AND THERE IS ALSO A LOCATION FOR THE CUSTOMER TO SIGN AND NOTE TIME OF RECEIPT. THIS STAMP DOCUMENTS THE AMOUNT OF TIME THE PRODUCT IS OUT OF REFRIGERATOR AND ON ICE. CARDINAL HEALTH RECEIVED NO NOTIFICATION OF THIS PRODUCT BEING RECEIVED PAST REQUIRED TIME FRAME. THERE IS NO EVIDENCE OF ANY TEMPERATURE ISSUE DURING THIS TIME WITH THE PRODUCT IN QUESTION. NO CUSTOMER COMPLAINTS HAVE BEEN RECEIVED FOR A TEMPERATURE ISSUE ON ITEM 4036025A. THERE WERE NO FINDINGS OF ANY FAILURES, THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS CASE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS REPORTED INCIDENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED BY CARDINAL HEALTH.

    Description of Event or Problem · 1

    PLAINTIFF ALLEGES THAT THE IFU FOR THE PIFA TEST HAS SPECIFIC STORAGE CONDITIONS. PLAINTIFF FURTHER ALLEGES THAT THE CARDINAL HEALTH DEFENDANTS WERE NEGLIGENT IN THE TRANSPORTATION, SHIPPING, STORAGE AND DISTRIBUTION OF THE PIFA TEST INCLUDING IN FAILING TO ENSURE THE PIFA TESTS WERE TRANSPORTED, SHIPPED, STORED, AND DISTRIBUTED IN ACCORDANCE WITH THE IFU; DELIVERING PIFA TESTS THAT HAD NOT BEEN TRANSPORTED, SHIPPED, STORED, AND DISTRIBUTED IN ACCORDANCE WITH THE REQUIREMENTS IN THE IFU; FAILING TO TAKE REASONABLE MEASURES TO PREVENT AFFECTED PIFA TESTS FROM BEING SOLD; FAILING TO REASONABLY ENSURE THAT THE PIFA TESTS REMAINED REFRIGERATED THROUGHOUT THE DISTRIBUTION PROCESS; AND FAILING TO ESTABLISH AND MAINTAIN QUALITY CONTROL TO PREVENT DEFECTIVE SHIPPING AND DISTRIBUTION OF THE PIFA TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155857 RAPID ASSAY PIFA HEPARIN PLATELET FACT4 PLATELET FACTOR 4 RADIOIMMUNOASSAY LCO CARDINAL HEALTH 200, LLC 4036025A UNKNOWN 00708872615123

    Patients

    Seq Age Sex Outcome Treatment
    1 Other