BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE

    MDR report key: 7986587 · Received October 19, 2018

    Report

    Report Number
    9616657-2018-00043
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Date of Event
    October 5, 2018
    Report Date
    November 2, 2018
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    00382903065721
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE SAMPLE UNIT WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER. UPON VISUAL INSPECTION OF THE SAMPLE, THE BARREL LABEL WAS OBSERVED MISSING. THE BARREL LABEL PROVIDES THE SCALE MARKINGS AS WELL AS THE PRODUCT INFORMATION, INCLUDING THE LOT NUMBER AND EXPIRATION DATE. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY DOCUMENTED QUALITY ISSUES DURING THE PRODUCTION OF LOT NUMBER 8143609 THAT COULD HAVE CONTRIBUTED TO THE OBSERVED DEFECT. BASED ON THE INVESTIGATION, IT HAS BEEN DETERMINED THAT THE MISSING BARREL LABELED WAS A RESULT OF A FAILURE IN THE VISION CAMERA. CORRECTIVE ACTION HAS BEEN INITIATED TO IMPROVE THE CAMERA DETECTION AND ENSURE DEFECTIVE PRODUCT IS DETECTED. COMPLAINTS FOR THIS DEFECT AND DEVICE WILL CONTINUE TO THE MONITORED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGES ARE MISSING SCALES ON THE SYRINGE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.(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 THAT BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGES ARE MISSING SCALES ON THE SYRINGE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828005 BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE SALINE FLUSH NGT BECTON, DICKINSON AND CO. 8143609 00382903065721

    Patients

    Seq Age Sex Outcome Treatment
    1 Other