BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%

    MDR report key: 8466396 · Received March 29, 2019

    Report

    Report Number
    1911916-2019-00327
    Event Type
    Malfunction
    Date Received
    March 29, 2019
    Date of Event
    March 21, 2019
    Report Date
    March 27, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. 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: BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. THIS IS THE 2ND COMPLAINT FOR THE LOT# 8172857 FOR THE SAME DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH 8172857 DURING THE PRODUCTION RUN. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE OF THE BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9% IT WAS DIFFICULT TO MOVE THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOME 10ML POSIFLUSH SYRINGES WILL STOP FLUSHING AFTER 5-7MLS. CUSTOMER NOTED THAT IF YOU DRAW UP SOME SODIUM CHLORIDE FROM AN AMPULE AND INJECT THAT, THEY ARE WORKING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260409 BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9% PRE-FILLED SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 8172857

    Patients

    Seq Age Sex Outcome Treatment
    1 Other