BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGO PET INFUSION SYSTEM

    MDR report key: 5843779 · Received August 3, 2016

    Report

    Report Number
    2520313-2016-00045
    Event Type
    Malfunction
    Date Received
    August 3, 2016
    Date of Event
    July 14, 2016
    Report Date
    January 9, 2017
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    LLY
    PMA / PMN Number
    K080297
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE LIMITED INFORMATION, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE PARTICLES AT THIS TIME; HOWEVER, THE PRODUCT IS SCHEDULED TO RETURN TO BAYER FOR A FULL EVALUATION. ONCE THE EVALUATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    BAYER PRODUCT ANALYSIS RECEIVED AND EXAMINED THE RETURNED SOURCE ADMINISTRATION SET (SAS) AND FDG VIALS. VISUALIZATION OF THE SAS NEEDLE TIPS UNDER MAGNIFICATION DETERMINED THE TIPS TO BE IN GOOD CONDITION WITH NO DAMAGE OBSERVED. VISUAL EXAMINATION OF SEVEN RETURNED USED 15ML FDG VIALS CONFIRMED THE PRESENCE OF A SINGLE SMALL PARTICLE SIMILAR IN COLOR TO THE MATERIAL OF THE RED RUBBER STOPPER INSIDE THREE OF THE VIALS. THE PARTICLES MEASURED 0.15 TO 0.60 MM2 RESPECTIVELY. THE COMPOSITION OF THE MATERIAL INDICATED THAT THE PARTICLES COULD POTENTIALLY BREAK APART WHILE UNDER PRESSURES TYPICALLY GENERATED DURING AN INFUSION AND, THEREFORE, BE INJECTED INTO A PATIENT. OUR INVESTIGATION DETERMINED THAT THE PARTICLES NOTED IN THE VIALS WERE INTRODUCED AS A RESULT OF FRAGMENTATION OF THE RED RUBBER STOPPERS DURING SPIKING WITH THE SAS. THIS INVESTIGATION REMAINS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    BAYER RADIOLOGY CONDUCTED A TECHNICAL EVALUATION OF THE INTEGO SOURCE ADMINISTRATION SET (SAS). THE FOLLOWING ARE THE CONCLUSIONS OF THAT ASSESSMENT: BAYER RADIOLOGY REVIEWED THE COMPLAINT RECORD AND PERFORMED DETAILED INTEGO SYSTEM LEVEL TESTING USING TWO DIFFERENT TYPES OF VIAL STOPPERS. VISIBLE PARTICULATES WERE GENERATED IN SEVERAL SAS NEEDLE INSERTIONS USING BOTH VIAL SEPTUM DESIGNS. INTEGO SAS NEEDLE TIPS ARE INTENDED TO BE NON-CORING. THE ORIGINAL DESIGN SPECIFICALLY DENOTED A "HUBER" NEEDLE, A TIP THAT IS INTENDED TO PREVENT THE REMOVAL OF THE SEPTUM MATERIAL DURING INSERTION. HOWEVER, FURTHER INVESTIGATION DETERMINED THAT THE SAS NEEDLES WERE MANUFACTURED WITH A SHARP EDGE AND DO NOT HAVE A ROUNDED HEEL EDGE THAT IS REQUIRED FOR ANTI-CORING PERFORMANCE. BAYER RADIOLOGY WILL INTEGRATE A FILTER INTO THE INTEGO STERILE DISPOSABLE SET AS A SOLUTION. ON DECEMBER 5, 2016, BAYER HEALTHCARE DISTRIBUTED A FIELD SAFETY CORRECTION NOTICE (FSCA) TO NOTIFY CUSTOMERS OF THE POTENTIAL FOR PARTICULATES TO BE GENERATED WHEN THE SAS NEEDLES ARE INSERTED INTO RADIOPHARMACEUTICAL (RP) VIALS. THIS FSCA INFORMED USERS THAT BAYER HAS SUCCESSFULLY TESTED AND QUALIFIED A COMPATIBLE IN-LINE FILTER THAT IS TO BE USED IN CONJUNCTION WITH THE PATIENT ADMINISTRATION SET (PAS) TO ELIMINATE THE POTENTIAL FOR INJECTION OF ANY PARTICULATES GENERATED DURING NEEDLE INSERTION AND IS NOW BEING PROVIDED AT NO COST FOR IMMEDIATE USAGE ON A COUNTRY-BY-COUNTRY BASIS.

    Description of Event or Problem · 1

    THE PHARMACIST AT THE CYCLOTRON FACILITY REPORTED THAT, UPON INSPECTION OF RETURNED USED FDG VIAL, SMALL PIECES OF THE RED RUBBER PLUG WERE SEEN WITHIN THE REMAINING FLUID AFTER HAVING BEEN PUNCTURED WITH THE NEEDLES THAT ARE PART OF THE MEDRAD INTEGO SOURCE ADMINISTRATION SET (SAS). NO INJURY OR ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496949 INTEGO PET INFUSION SYSTEM PET INFUSION SYSTEM LLY BAYER MEDICAL CARE, INC. 3029151

    Patients

    Seq Age Sex Outcome Treatment
    1