BEUDAMED
    FDA Adverse Event Summary report: N

    STARSWAB

    MDR report key: 11542 · Received February 7, 1994

    Report

    Report Number
    MW4000213
    Date Received
    February 7, 1994
    Report Date
    April 20, 1993
    Manufacturer
    STARPLEX SCIENTIFIC
    Product Code
    JTW
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    RPTR HAS BEEN USING THIS PRODUCT AS A TRANSPORT MEDIUM FOR ALL WOUND CULTURES FOR 3-4 YRS. IT IS PROCEDURE (AS REQUIRED BY COLLEGE OF AMERICAN PATHOLOGISTS) TO DO DIRECT SMEARS ON ALL WOUND CULTURES WITH SAME DAY REPORTING WHENEVER AT ALL POSSIBLE. A FEW WKS AGO, RPTR BECAME AWARE THAT HOSP WAS SEEING GRAM NEGATIVE BACILLI (BACTERIA) ON DIRECT SMEARS FROM WOUND CULTURE SPECIMENS SUBMITTED IN THE TRANSPORT MEDIA FROM SOURCES THAT ONE WOULD NORMALLY CONSIDER STERILE SITES (IE BONE SHAFT, PERITONEAL FLUIDS) AND IN FAIRLY LARGE NUMBER (UP TO 3-4 OR MORE/HPF). RPTR'S FIRST THOUGHT WAS THAT THIS WAS A LAB CONTAMINANT POSSIBLY IN THE WATER USED TO WASH OFF THE SLIDES, OR IN THE STAIN REAGENT THEMSELVES, OR ON THE SLIDES. RPTR DID ALL KINDS OF EXPERIMENTS TO RULE OUT EACH POSSIBLITY BUT THEY WERE STILL THERE. THE CULTURES IN ALL CASES SHOWED NO GROWTH EITHER AEROBIC OR ANAEROBICALLY. RPTR THEN DECIDED IT MUST BE IN THE TRANSPORT MEDIA AND DID A GRAM STAIN ON ANOTHER CO'S UNINOCULATED TRANSPORT MEDIA USING THE SWABS AND DISOVERED THE ORGANISMS (UP TO 3-4/HPF) IN THE OTHER CO'S TRANSPORT MEDIA. RPTR CALLED THE MFR. MFR'S QC PERSON KNEW THERE WAS A PROBLEM WITH "BACKGROUND" ON THIS LOT #. HE STATED THAT THEY HAD NOTIFIED THEIR DISTRIBUTORS TO ALERT THEIR CUSTOMERS OF A PROBLEM WITH "BACKGROUND" USING THIS (AND OTHER LOT #'S) FOR GRAM STAIN PURPOSES. AFTER FURTHER RESEARCH RPTR FOUND THAT THE FDA ALLOWS UP TO 1 ORGANISM/HPF (NON-VIABLE OF COURSE) ON GEL TYPE TRANSPORT MEDIA. THE SITUATION WITH THIS LOT # FAR EXCEEDS 1 ORGANISM/HPF AND YET MFR IS SELLING ITS PRODUCT. RPTR ALSO FEELS FDA'S TOLERANCE LIMITS ARE MUCH TOO GENEROUS. IF THAT WERE A VIABLE ORGANISM IT WOULD PROBABLY TRANSLATE INTO A MODERATE NUMBER OF COLONIES OF ORGANISM. WHEN RPTR REPORTS A FEW ORGANISMS FROM A DIRECT SMEAR (MEANING 1-5 ORGANISM ARE PRESENT AND THAT ACCORDINGLY WITH ANTIBIOTICS. RPTR IS CONCERNED ABOUT THE QUALITY CONTROL OF THIS PRODUCT AS WELL AS FDA'S GENEROUS TOLERANCE LIMITS ON GEL AGAR TRANSPORT MEDIA OF 1 ORGANISM/HPF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARSWAB JTW STARPLEX SCIENTIFIC S130D

    Patients

    Seq Age Sex Outcome Treatment
    1 *