BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHATMAN BODY FLUID COLLECTION PAPER '903'

    MDR report key: 2059221 · Received March 10, 2011

    Report

    Report Number
    1281317-2011-00001
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    January 1, 2010
    Report Date
    February 10, 2011
    Manufacturer
    GE HEALTHCARE, BIO-SCIENCES CORP.
    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

    ADD'L: MODEL #: 10535136. MEDICAL DEVICES UNDER INVESTIGATION: PART #: 10535134; LOT #: W092-6868610; DEVICE MANUFACTURE DATE: 08/2010; EXPIRATION DATE: 04/30/2013. PART #: 10535136, LOT #: W092-6864110; DEVICE MANUFACTURE DATE: 05/2010; EXPIRATION DATE: 04/30/2013. PART #: 10535136; LOT #: W092-6868710; DEVICE MANUFACTURE DATE: 08/2010; EXPIRATION DATE: 04/30/2013. GE HEALTHCARE'S INVESTIGATION OF THIS COMPLAINT IS NOT COMPLETE. GE HEALTHCARE WILL SUBMIT A FOLLOW-UP REPORT ON OR BEFORE (B)(4) 2011, WHICH WILL DETAIL THE RESULTS OF ITS INVESTIGATION OR A CONFIRMATION WHEN THE INVESTIGATING WILL BE COMPLETED, AND A FURTHER FOLLOW-UP REPORT WILL BE SUBMITTED. MEDICAL DEVICES UNDER INVESTIGATION: PART #: 10535134, LOT #: W092-6864010, DEVICE MANUFACTURE DATE: 05/2010, EXPIRATION DATE: 04/30/2013. PART #: 10535134, LOT #: W092-6868610, DEVICE MANUFACTURE DATE: 08/2010, EXPIRATION DATE: 04/30/2013. PART #: 10535136, LOT #: W092-6864110, DEVICE MANUFACTURE DATE: 05/2010, EXPIRATION DATE: 04/30/2013. PART #: 10535136, LOT #: W092-6868710, DEVICE MANUFACTURE DATE: 08/2010, EXPIRATION DATE: 04/30/2013.

    Description of Event or Problem · 1

    THE DEVICE IS USED BY HEALTH CARE 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 (I) FILTER PAPER TO WHICH THE INFANT'S BLOOD IS APPLIED (II) A FORM ONTO WHICH THE INFANT'S DEMOGRAPHIC DETAILS ARE RECORDED. THE 903 CARD SUPPLIED TO NEWBORN SCREENING PROGRAM, (B)(6) IS A CUSTOMIZED CARD, WHICH THE CUSTOMER DESIGNED 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 GE HEALTHCARE, BIO-SCIENCES CORP. 10535134 W092-6864010

    Patients

    Seq Age Sex Outcome Treatment
    1