BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHATMAN BODY FLUID COLLECTION PAPER '903'

    MDR report key: 1638439 · Received March 18, 2010

    Report

    Report Number
    1281317-2010-00001
    Event Type
    Malfunction
    Date Received
    March 18, 2010
    Date of Event
    January 1, 2009
    Report Date
    February 11, 2010
    Manufacturer
    WHATMAN, INC.
    Product Code
    JKA
    PMA / PMN Number
    K932661
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MODEL # 10535136. ADDITIONAL LOT #6833308. WHATMAN'S INVESTIGATION OF THIS COMPLAINT IS NOT COMPLETE. WHATMAN WILL SUBMIT A FOLLOW-UP REPORT ON OR BEFORE 04/19/2010, WHICH WILL DETAIL THE RESULTS OF ITS INVESTIGATION OR A CONFIRMATION WHEN THE INVESTIGATION WILL BE COMPLETED AND A FURTHER FOLLOW-UP REPORT WILL BE SUBMITTED. AT ITS MEETING WITH THE REPORTING USER ON 03/09/2010, WHATMAN WAS GIVEN 903 PAPER, SPOTTED WITH BLOOD, WHICH THE REPORTING USER STATES; THE BLOOD DID NOT VISUALLY APPEAR TO HAVE UNIFORMLY ABSORBED INTO THE FILTER PAPER. WHATMAN'S EXAMINATION OF THE SAMPLE WILL INCLUDE EXPERT REVIEW BY THE NEWBORN SCREENING UNIT, CENTRE FOR DISEASE CONTROL, ATLANTA TOGETHER WITH CHEMICAL ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    THE DEVICE IS USED BY HEALTHCARE PROFESSIONALS IN THE COLLECTION AND IN-VITRO STORAGE OF NEONATE BLOOD. THE NEONATE BLOOD IS TESTED TO SCREEN THE INFANT FOR CONGENITAL ABNORMALITIES OF METABOLISM AND OTHER CONDITIONS. THE DEVICE IS PRESENTED AS JOINED PARTS WHICH CONSTITUTE THE TOTAL DEVICE PRESENTATION; THESE PARTS ARE, FILTER PAPER TO WHICH THE INFANT'S BLOOD IS APPLIED AND A FORM ONTO WHICH THE INFANT'S DEMOGRAPHIC DETAILS ARE RECORDED. THE 903 CARD SUPPLIED TO NEWBORN SCREENING PROGRAM, (B)(4) IS A CUSTOMIZED CARD WHICH THE CUSTOMER DESIGNS IN PARTNERSHIP WITH WHATMAN, TO MEET THE CUSTOMER REQUIREMENTS FOR NEWBORN SCREENING. THE COMPLAINT FROM THE CUSTOMER WAS THAT FOR A SMALL NUMBER OF CARDS, BLOOD SPOTS APPLIED TO THE FILTER PAPER PORTION OF THE CARD, WHEN DRIED, DID NOT VISUALLY APPEAR TO HAVE UNIFORMLY ABSORBED INTO THE FILTER PAPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHATMAN BODY FLUID COLLECTION PAPER '903' JKA WHATMAN, INC. 10535134 W81 6823408

    Patients

    Seq Age Sex Outcome Treatment
    1