BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE

    MDR report key: 7730889 · Received July 30, 2018

    Report

    Report Number
    9616657-2018-00036
    Event Type
    Malfunction
    Date Received
    July 30, 2018
    Date of Event
    July 6, 2018
    Report Date
    August 27, 2018
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT TRENDING REVIEW OF THE LOT (8011753) FOR THIS IS ISSUE REVEALS THIS IS THE FIRST COMPLAINT. THE NON-CONFORMANCES WERE REVIEWED FOR THIS BATCH; THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS DEFECT. THE RETURNED PHOTOS WERE REVIEWED BUT THE COMPLAINT COULD NOT BE SUBSTANTIATED. NO SAMPLES WERE RETURNED IN SUPPORT OF THIS COMPLAINT. DHR REVIEW INDICATED THAT THERE WERE NO INCIDENTS WHICH MAY HAVE ATTRIBUTED TO THE FAILURE MODE, THE PRODUCT IS DESIGNED TO ALLOW THE USER TO DRAW THE PLUNGER BACK SLOWLY AND NOT IN A SHARP/EXERTED MOTION. HOWEVER, FROM THE VERBATIM TEXT CONTAINED IN THE REPORT, IT IS POSSIBLE THAT THE END USER MAY HAVE PULLED BACK ON THE PLUNGER AND DETACHED IT FROM THE STOPPER. THE PRODUCT IS DESIGNED TO ENABLE THE PLUNGER TO BE DRAWN BACKWARDS BUT IN A SLOW AND EVEN ACTION. ADDITIONAL TRAINING IN THE USE OF THE PRODUCT IS ADVISED, AND HAS BEEN COMMUNICATED TO THE REGIONAL MARKETING REPRESENTATIVES. DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: NO.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE THERE WAS AN ISSUE WITH PLUNGER ERROR. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE THERE WAS AN ISSUE WITH PLUNGER ERROR. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575135 BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE SALINE FLUSH NGT BECTON, DICKINSON AND CO. 8011753

    Patients

    Seq Age Sex Outcome Treatment
    1 Other