BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ SYRINGE

    MDR report key: 8465447 · Received March 29, 2019

    Report

    Report Number
    1911916-2019-00323
    Event Type
    Malfunction
    Date Received
    March 29, 2019
    Date of Event
    February 25, 2019
    Report Date
    March 29, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    N/A
    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. 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. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. THIS IS THE 2ND COMPLAINT FOR LOT # 8082843 FOR THIS TYPE OF DEFECT OR SYMPTOM. PREVIOUS COMPLAINT 8082843.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ SYRINGE PLUNGER WAS FOUND BROKEN BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "IT WAS FOUND THE PLUNGER BROKEN BEFORE USING,THEN REPLACED A NEW FLUSH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260579 BD POSIFLUSH¿ SYRINGE PRE-FILLED SYRINGE NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 8082843

    Patients

    Seq Age Sex Outcome Treatment
    1 Other