BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 8597209 · Received May 9, 2019

    Report

    Report Number
    1911916-2019-00460
    Event Type
    Malfunction
    Date Received
    May 9, 2019
    Date of Event
    April 1, 2019
    Report Date
    April 26, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    K982558
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. 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. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. 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: THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. THIS IS THE 1ST COMPLAINT FOR LOT # 8072904 FOR THIS TYPE OF DEFECT OR SYMPTOM. ROOT CAUSE DESCRIPTION: UNDETERMINED. RATIONALE: NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING USING, IT WAS FOUND THAT THE FLANGE BROKEN AND MISSING .REPLACING A NEW FLUSH TO SOLVE THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387546 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE FLUSH SYRINGE NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 8072904

    Patients

    Seq Age Sex Outcome Treatment
    1 Other