BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRE-FILLED POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 9125915 · Received September 26, 2019

    Report

    Report Number
    1911916-2019-01019
    Event Type
    Malfunction
    Date Received
    September 26, 2019
    Date of Event
    September 12, 2019
    Report Date
    September 16, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    00382903064991
    PMA / PMN Number
    K161552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: TWO SAMPLES WERE RECEIVED. ONE SAMPLE HAS THE PLUNGER ROD-RUBBER STOPPER ALL THE WAY DOWN. IT HAS THE TIP CAP, THERE IS NO SOLUTION. VISUAL INSPECTION WAS PERFORMED, THERE IS NO STOPPER SEPARATION FROM PLUNGER. THE OTHER SAMPLE HAS THE STOPPER AT 5.5 ML, IT HAS PLUNGER ROD, TIP CAP AND SOLUTION. VISUAL INSPECTION WAS PERFORMED THERE IS NO STOPPER SEPARATION FROM PLUNGER. NO MANUFACTURING ISSUES WERE EXPERIENCED DURING THE PRODUCTION OF THESE PRODUCTS. AT THE PLUNGER ROD LABELER EQUIPMENT, WE HAVE AN INSPECTION FOR STOPPER SEPARATION; ALL INSPECTIONS WERE ACCEPTED. ROOT CAUSE CANNOT BE CONFIRMED. NO MANUFACTURING ISSUES WERE EXPERIENCED DURING THE PRODUCTION OF THESE PRODUCTS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PRE-FILLED POSIFLUSH¿ NORMAL SALINE SYRINGE PLUNGER DISCONNECTED DURING USE. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306499. BATCH/LOT: 9002663. IT WAS REPORTED THAT THE "PLUNGER BECOMES DISCONNECTED WHILE FLUSHING A MEDIPORT". CUSTOMER TEXT: WE HAVE BEEN HAVING DIFFICULTIES WITH FLUSH SYRINGES. THE ISSUE SEEMS TO BE THE PLUNGER BECOMING DISCONNECTED WHILE FLUSHING A MEDIPORT. IT¿S HAPPENED AT LEAST THREE TIMES, BUT ONLY ONE HAS BEEN SAVED BECAUSE THE OTHERS WERE CONTAMINATED WITH BLOOD AND WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920632 BD PRE-FILLED POSIFLUSH¿ NORMAL SALINE SYRINGE INTRAVASCULAR CATHETER NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 9002663 00382903064991

    Patients

    Seq Age Sex Outcome Treatment
    1 Other