BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 8901076 · Received August 16, 2019

    Report

    Report Number
    1911916-2019-00822
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    July 25, 2019
    Report Date
    August 5, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065470
    PMA / PMN Number
    K161552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE SAMPLE WAS RECEIVED. IT CAME IN A ZIPLOC PLASTIC BAG. IT HAS THE PLUNGER ROD-RUBBER STOPPER, NO TIP CAP AND NO SOLUTION. THE RUBBER STOPPER IS ALL THE WAS DOWN, THE BOTTOM PART OF THE STOPPER HAS BLOOD. THE POSIFLUSH SP SYRINGES ARE DESIGNED TO FLUSH THE IV LINES NOT TO DRAW LAB BLOOD SAMPLES AFTER EXPELLING THE SALINE SOLUTION. 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: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. THIS IS THE 1ST COMPLAINT FOR THE LOT# 9113775 FOR THE SAME DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH 9113775 DURING THE PRODUCTION RUN. ROOT CAUSE DESCRIPTION: THIS IS OFF LABEL USE. THE POSIFLUSH SP SYRINGES ARE DESIGNED TO FLUSH THE IV LINES NOT TO DRAW LAB BLOOD SAMPLES AFTER EXPELLING THE SALINE SOLUTION. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE LEAKED BLOOD PAST THE STOPPER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "REPORT WAS 10 CC SYRINGE FAULTY BLOOD LEAKED TO THE OUTSIDE OF THE RUBBER STOPPER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694664 BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 9113775 30382903065470

    Patients

    Seq Age Sex Outcome Treatment
    1 Other