BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 976529 · Received May 29, 2007

    Report

    Report Number
    3004147784-2007-00015
    Event Type
    Other
    Date Received
    May 29, 2007
    Manufacturer
    GETINGE USA, INC
    Product Code
    FRC
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    GETINGE REP VISITED THE CUSTOMER SITE TO INVESTIGATE THE PROBLEM VIALS. CUSTOMER COULD NOT LOCATE THE 2 VIALS THAT HAD DRIED UP. ALL OTHER VIALS RECEIVED FROM THAT LOT WERE OK. LABELING ON THE PRODUCT INSTRUCTS THE USER TO OBSERVE THE AMPULE THROUGH THE WINDOW PROVIDED AND TO NOT USE IF THE AMPULE IS DRY OR DISCOLORED. CUSTOMER STATED THAT THEY DID NOT LOOK AT THE AMPULE PRIOR TO PROCESSING THE VIAL. IT WAS UNABLE TO DETERMINE WHEN THE MEDIA AMPULE BREAKAGE OCCURRED. IT IS POSSIBLE FOR AMPULES TO BREAK DURING HANDLING ALTHOUGH THE OCCURRENCE IS NOT FREQUENT. CUSTOMER WILL ADD INSPECTION TO POLICY AND NOTIFY GETINGE IF PROBLEM CONTINUES. THERE WAS NO EVIDENCE TO SUPPORT THE STATEMENT REGARDING MISSING STRIPS. NO DETAILS WERE ABLE TO BE OBTAINED ABOUT THIS ALLEGED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * FRC GETINGE USA, INC BIOSIGN SSI *

    Patients

    Seq Age Sex Outcome Treatment
    1