BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0.8% RESOLVE PANEL B

    MDR report key: 1614076 · Received February 24, 2010

    Report

    Report Number
    2250051-2010-00035
    Event Type
    Injury
    Date Received
    February 24, 2010
    Date of Event
    January 17, 2010
    Report Date
    February 16, 2010
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MED TECH INDICATES THAT THE VIAL TO CELL 19 HAD A NORMAL APPEARANCE AND THE CAP WAS STILL ATTACHED WHEN THE ATTEMPT TO OPEN IT WAS BEING PERFORMED. VIAL TORQUE CONFIRMED TO BE NORMAL COMPARED TO ALL OTHER VIALS TO THE PANEL. UNIT USED IN THE MANUFACTURE OF (B) (4) CELL 19 HAS BEEN FOUND NON-REACTIVE BY AN FDA APPROVED TEST METHOD FOR HBSAG, HBCAB, (B) (6) 1/2 PLUS O, HTLV I/II AB, HCV AB, T. CRUZI ANTIBODIES, SYPHILIS AND FOR HCV RNA AND (B) (6)-1 RNA IN A POOL. (B) (4) : VIAL DISCARDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A MED TECH CUT HIS FINGER WHILE ATTEMPTING TO OPEN CELL 19 (DONOR (B) (6)), (B) (4). MED TECH UNSURE IF ANY OF THE REAGENT RED CELLS ENTERED THE CUT. OCD'S MEDICAL DIRECTOR HAS CLASSIFIED THIS EVENT AS A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% RESOLVE PANEL B REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other