BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD

    MDR report key: 9203746 · Received October 17, 2019

    Report

    Report Number
    1911916-2019-01100
    Event Type
    Malfunction
    Date Received
    October 17, 2019
    Date of Event
    September 29, 2019
    Report Date
    October 7, 2019
    Manufacturer
    BECTON DICKINSON AND COMPANY
    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

    INITIAL REPORTER FACILITY: THE USER FACILITY ADDRESS IS NOT AVAILABLE, THE CORPORATE HEADQUARTERS INFORMATION WAS USED INSTEAD. INVESTIGATION SUMMARY: ONE SAMPLE WAS RECEIVED. IT HAS THE PLUNGER ROD-RUBBER STOPPER, NO TIP CAP, AND IT HAS 3ML OF SALINE SOLUTION; THE RUBBER STOPPER IS AT 4.5ML. THE PLUNGER ROD WAS REMOVED FROM THE SYRINGE. NO MANUFACTURING ISSUES WERE EXPERIENCED DURING THE PRODUCTION OF THESE PRODUCTS. THE BARREL HAS A RETAINING RING AT THE INNER BARREL WALL SO THE PLUNGER ROD STOPS AT THAT POINT. THE PLUNGER ROD WAS ASSEMBLED BACK INTO THE SYRINGE AND VERIFIED THE PERFORMANCE PUSHING THE PLUNGER ROD DOWN. IT WORKED WITH NO ISSUES. 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. POSSIBLE ROOT CAUSE, OFF LABEL USE. THE SYRINGE IS DESIGNED TO FLUSH THE IV LINES BY PUSHING THE PLUNGER ROD DOWN, NOT TO PULL THE PLUNGER ROD UP AND REMOVING IT FROM THE SYRINGE. 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 HAS BEEN REPORTED THAT ONE SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD HAS BEEN FOUND WITH STOPPER SEPARATION FROM THE PLUNGER DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE PLUNGER ROD SEPARATED FROM THE STOPPER AND PULLED OUT OF THE SYRINGE. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: DATE OF OCCURRENCE: (B)(6) 2019. PRODUCT ITEM NUMBER: 306499. LOT NUMBER: 9002663. DESCRIPTION: ¿PLUNGER PULLED OUT OF FLUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000007 SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD INTRAVASCULAR CATHETER NGT BECTON DICKINSON AND COMPANY 9002663 00382903064991

    Patients

    Seq Age Sex Outcome Treatment
    1 Other