BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD

    MDR report key: 8905862 · Received August 19, 2019

    Report

    Report Number
    1911916-2019-00831
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Date of Event
    July 10, 2019
    Report Date
    August 9, 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
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE SAMPLES WAS RECEIVED. IT HAS THE PLUNGER ROD- RUBBER STOPPER; NO TIP CAP AND NO SALINE SOLUTION. THE RUBBER STOPPER IS ALL THE WAY DOWN. THE PLUNGER ROD IS SEPARATED FROM THE RUBBER STOPPER. IT HAS BLOOD IN IT. THE POSIFLUSH PRODUCT IS DESIGNED TO FLUSH THE IV LINES, ONE SINGLE USE, NOT TO DRAWING BLOOD. 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR THE LOT# 9002663 FOR THE SAME DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH 9002663 DURING THE PRODUCTION RUN. ROOT CAUSE DESCRIPTION: ROOT CAUSE OFF LABEL USE. RATIONALE: THE POSIFLUSH PLATFORM WAS INFORMED OF THE OFF-LABEL USE TO ADDRESS THIS WITH THE CUSTOMER BY THE MARKETING TEAM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD EXPERIENCED DIFFICULT PLUNGER MOVEMENT AND STOPPER SEPARATION FROM PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 306499 , BATCH NO: 9002663. VERBATIM: THE FLUSHES ARE NOT COMING APART UNLESS LABS ARE BEING DRAWN AND THE NURSES ARE PULLING BACK TO OBTAIN THE WASTE. THE HANDLE CAN BE SCREWED BACK INTO THE RUBBER PIECE, BUT THAT IS NOT BEST PRACTICE EITHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698590 SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD INTRAVASCULAR CATHETER NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 9002663 00382903064991

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other