BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 8654265 · Received May 30, 2019

    Report

    Report Number
    1911916-2019-00537
    Event Type
    Malfunction
    Date Received
    May 30, 2019
    Date of Event
    September 3, 2018
    Report Date
    May 14, 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: NO SAMPLES WERE RECEIVED. NO PHOTOS WERE PROVIDED. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR LOT # 8141929 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: ROOT CAUSE CAN¿T BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAKAGE PAST THE STOPPER WITH A 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 306547, BATCH NO. 8141929. (9 OF 13). IT WAS REPORTED THERE WAS LEAKAGE. "SYRINGE LEAKED BLOOD BACK INTO THE PLUNGER ONTO THE TECHNICIAN'S GLOVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446112 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 8141929 30382903065470

    Patients

    Seq Age Sex Outcome Treatment
    1 Other