BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMUSA FLUSH SYRINGE

    MDR report key: 5783902 · Received July 11, 2016

    Report

    Report Number
    1000151124-2016-00001
    Event Type
    Malfunction
    Date Received
    July 11, 2016
    Date of Event
    April 7, 2015
    Report Date
    July 5, 2016
    Manufacturer
    AQUABILITI
    Product Code
    NGT
    PMA / PMN Number
    K111034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO EVALUATE ANY HEALTH CONCERNS REGARDING THE CLOUDINESS IN THE SALINE SOLUTION OBSERVED IN THE REPORTED PRODUCT, AQUABILITI CONTRACTED INTEGRATED ANALYTICAL LABORATORIES LLC (IAL) TO CONDUCT INORGANIC TEST OF THE SOLUTIONS FROM THE CLOUDY SYRINGE. AQUABILITI ALSO SENT A RETAINED SAMPLE FROM LOT KH040162 TO BE LIKEWISE TESTED AS A CONTROL SAMPLE. THE CONCLUSION IS THAT THE ALLOWABLE LIMITS, BASED ON MG/KG BODY WEIGHT, DEMONSTRATE THAT ALL PATIENTS AND BODY MASSES HAVE TOLERABLE INTAKE (TI) LEVELS WELL ABOVE THE EXPOSURE LEVELS OF THE INORGANIC REPORTED IN THE IAL REPORT. BOTH REPEATED AND LONG-TERM USE OF THE REPORTED DEVICE, INCLUDING PEDIATRIC AND NEONATE POPULATIONS, WOULD BE CONSIDERED REASONABLY SAFE WITHOUT SIGNIFICANT TOXICOLOGICAL CONCERNS. ALLOWABLE LIMITS WERE CALCULATED IN ACCORDANCE WITH THE METHODS DESCRIBED IN ANSI/AAMI/ISO 10993-17:2002 BIOLOGICAL EVALUATION OF MEDICAL DEVICES-PART 17: METHODS FOR THE ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES.

    Additional Manufacturer Narrative · 1

    SYRINGE PLUNGER TIP MANUFACTURER REPORTED OCCASIONALLY A SMALL SHARD OF METAL FROM THE PROCESS CAN BECOME LODGED IN THE MATERIAL THAT IS INJECTION MOLDED. THEY INDICATED SEVERAL QUALITY CHECKS EXIST IN THEIR PRODUCTION LINE TO CATCH ANY PLUNGER TIPS THAT HAVE ANY METAL IN THEM, BUT ADMIT THAT IT IS A POSSIBLE OCCURRENCE. RESULTS OF CHEMICAL (INORGANIC) ANALYSES UNDER REVIEW.

    Description of Event or Problem · 1

    APPEARANCE OF A GROWTH ON THE RUBBER STOPPER (INSIDE OF SYRINGE) AND A DARK ORANGE-BROWN SALINE COLOR. THE SYRINGE WAS NOT USED ON A PATIENT AND WAS NOT REMOVED FROM ITS PACKAGING. UPON VISUAL EVALUATION OF THE RETURNED SYRINGE IT APPEARED THAT A SMALL PIECE OF METAL WAS LODGED IN THE PLUNGER TIP, WHICH HAD THEN CORRODED WITH EXPOSURE TO THE SALINE SOLUTION IN THE SYRINGE THUS CAUSING THE CLOUDINESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437441 AMUSA FLUSH SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT AQUABILITI 2T0806 KH04162

    Patients

    Seq Age Sex Outcome Treatment
    1 Other