BEUDAMED
    FDA Adverse Event Injury Summary report: N

    150 ML ANGIOGRAPHIC SYRINGE FOR MEDRAD MARK V INJ.

    MDR report key: 117203 · Received August 25, 1997

    Report

    Report Number
    2411512-1997-00003
    Event Type
    Injury
    Date Received
    August 25, 1997
    Date of Event
    July 14, 1997
    Report Date
    July 28, 1997
    Manufacturer
    COEUR LABORATORIES, INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME IN WHICH THE COMPLAINT WAS RECEIVED, THE HOSPITAL INDICATED THAT THE PRODUCT WAS SENT OUT FOR INDEPENDENT EVAL AND WOULD LIKELY BE AVAILABLE AT A LATER DATE. E-Z-EM, INC CONTINUED TO FOLLOW UP WITH THE COMPLAINANT (VIA TELEPHONE AND IN WRITING) REGARDING THE AVAILABILITY OF THE PRODUCT. THE LAST CORRESPONDANCE WAS A MESSAGE LEFT WITH E-Z-EM, INC ON 9/22 INDICATING THE PRODUCT WAS NOT YET AVAILABLE. E-Z-EM, INC. ATTEMPTED TO CONTACT COMPLAINANT ONE ADDITIONAL TIME SINCE THEN AND HAS NOT HEARD BACK FROM HER. THE VENDOR WHO MANUFACTURES THIS PRODUCT HAS BEEN NOTIFIED OF THIS REPORT. THE VENDOR STATED THAT THEY CANNOT CONCLUDE WHY THE CUSTOMER EXPERIENCED POSSIBLE AIR INJECTION DURING CATHETERIZATION. WITHOUT A SYRINGE OR THE SPECIFIC LOT NUMBER AN INVESTIGATION CANNOT BE PERFORMED TO DETERMINE THE CAUSE OF THE PROBLEM EXPERIENCED BY THE CUSTOMER. IT IS THE OPINION OF E-Z-EM'S MEDICAL AFFAIRS DIRECTOR THAT IT IS NOT CERTAIN THAT A SUFFICIENT AMOUNT OF AIR (IF ANY) TO CAUSE THE CARDIAC ARREST WAS ADMINISTERED. IT IS POSSIBLE THAT THE PTS DISEASE OR AN ALLERGIC REACTION TO THE IODINATED CONTRAST MEDIA WAS RESPONSIBLE FOR THE ARREST. IF AIR ADMINISTERED WAS THE CAUSE IT WAS LIKELY FAULTY TECHNIQUE IN CLEARING THE IV LINE BEFORE USING IT RATHER THAN THE SYRINGE. H6: CONCLUSION- POSSIBLE USER ERROR OR ALLERGIC REACTION TO CONTRAST.

    Description of Event or Problem · 1

    POSSIBLE AIR INJECTION DURING CARDIAC CATHETERIZATION. PT SUFFERED CARDIAC ARREST. LEFT ANTERIOR DESCENDING ARTERY BLOCKED - OPENED WITH TWO STENTS. RESUSCITATION WAS SUCCESSFUL - NO NEURO DEFICITS. INJECTOR WAS IN USE WITH ANOTHER CO'S ANGIOGRAPHIC SYRINGE AND ANGIOGRAPH KIT/CARDIAC CATH LAB MANIFOLD KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 150 ML ANGIOGRAPHIC SYRINGE FOR MEDRAD MARK V INJ. ANGIOGRAPHIC SYRINGE DXT COEUR LABORATORIES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L ANGIOGRAPH KIT. INFO ON DRUG NOT AVAILABLE.| MEDRAD MARKU PLUS INJECTOR/NAMIC CUSTOM