BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO-VENT(TM), PULSATOR(R), AND LINE DRAW

    MDR report key: 15328053 · Received August 31, 2022

    Report

    Report Number
    3012307300-2022-17035
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Date of Event
    February 4, 2020
    Report Date
    August 31, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JKA
    PMA / PMN Number
    K945777
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW FOUND NO DISCREPANCIES OR ANOMALIES RELEVANT TO THE COMPLAINT. TWO PRODUCT SAMPLES AND PHOTO WERE RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. THE PHOTO SHOWED THE SYRINGE, TO HAVE A DEFORMED (OVAL SHAPED, NOT CIRCULAR) LUER-LOCKING COLLAR. THE VISUAL INSPECTION ALSO REVEALED THAT BOTH OF THE RETURNED NEEDLE-PRO DEVICES HAD ALREADY BEEN ACTIVATED (NEEDLE CANNULA ENGAGED WITHIN THE SAFETY MECHANISM). TO DETERMINE IF THE RETURNED SYRINGE SAMPLES (ONE WITH CIRCULAR COLLAR AND ONE WITH OVAL COLLAR) WOULD FUNCTION WHEN ASSEMBLED WITH AN EDGE NEEDLE-PRO DEVICE AND IN ORDER TO RECREATE WORST CASE LEAKAGE CONDITION AT MATING LUERS, THE SAMPLES WERE TESTED ACCORDING. THE RETURNED SYRINGES WERE FILLED WITH FLUID AND WERE THEN ASSEMBLED TO EDGE NEEDLE-PRO DEVICES, FROM STOCK. BECAUSE THE RETURNED EDGE NEEDLE-PRO DEVICES HAD ARRIVED ALREADY ACTIVATED, NEW SAMPLES WERE OBTAINED FROM STOCK FOR TESTING PURPOSES. NO LEAKAGE OR SEPARATION OF THE COMPONENTS WERE OBSERVED ON EITHER SAMPLE. THE RETURNED SYRINGE SAMPLES FUNCTIONED AS INTENDED WHEN ASSEMBLED TO NEEDLE-PRO DEVICES. THE RISK, ASSOCIATED WITH BLOOD EXPOSURE, MENTIONED BY THE CUSTOMER, COULD NOT BE REPLICATED OR CONFIRMED BASED ON THE PROVIDED SAMPLES. THE MAINTENANCE LOGBOOK WAS CHECKED FOR ENTRIES MADE ON THE DATE OF MANUFACTURING WHICH WOULD EXPLAIN THE OVAL SHAPE TO THE COLLAR. NO ENTRIES WERE FOUND. THE SUPPLIER WAS INFORMED REGARDING THE OVAL SHAPED COLLAR. WHILE THE OVAL SHAPE OF THE LUER LOCK COLLAR ON ONE OF THE RETURNED SAMPLES WAS CONFIRMED, THE SYRINGE REMAINED TO BE FUNCTIONAL. THE CAUSE FOR THE OVAL SHAPED COLLAR ON THE RETURNED SYRINGE COULD NOT BE DETERMINED AT THIS TIME. HOWEVER, COMPLAINT INFORMATION WILL CONTINUE TO BE MONITORED FOR ANY NEW INFORMATION OR ADVERSE TRENDS AND FURTHER ACTIONS WILL BE TAKEN ACCORDINGLY. UDI IS UNKNOWN. OPERATOR OF DEVICE IS UNKNOWN. INITIAL REPORTER ALSO SENT REPORT TO FDA IS UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THE TIP OF THE PRO-VENT SYRINGE WAS MALFORMED. DIFFICULTY TO WITHDRAW THE NEEDLE AFTER COLLECTION, BLOOD PROJECTION, BUT RISK OF ACCIDENT OF EXPOSURE TO BLOOD. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2305265 PRO-VENT(TM), PULSATOR(R), AND LINE DRAW TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD JKA SMITHS MEDICAL ASD, INC. 3886682

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown