BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ SF SALINE SYRINGE

    MDR report key: 7889168 · Received September 19, 2018

    Report

    Report Number
    9616657-2018-00041
    Event Type
    Malfunction
    Date Received
    September 19, 2018
    Date of Event
    August 28, 2018
    Report Date
    November 6, 2018
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    30382903065531
    PMA / PMN Number
    K153481
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIX PHYSICAL SAMPLES AND ONE PICTURE SAMPLE BELONGING TO LOT NUMBER 8150692 WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY QUALITY ISSUES DURING THE PRODUCTION OF LOT NUMBER 8150692 THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. UPON INSPECTION OF THE SAMPLES, GREEN TAPE WAS OBSERVED ON THE PRODUCT PACKAGING. THE GREEN TAPE OCCURS DURING THE ATTACHMENT OF THE LAST PACKAGING LABELS. THE GREEN TAPE PREVENTS A PROPER SEAL. THIS ISSUE IS RELATED TO THE LABELING SUPPLIER AND THEREFORE, A SUPPLIER CORRECTION ACTION REQUEST HAS BEEN SUBMITTED TO FURTHER INVESTIGATION THIS ISSUE AND PREVENT ITS REOCCURRENCE. THIS ISSUE WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD POSIFLUSH SF SALINE SYRINGE THAT GREEN LIKE TAPE WENT ACROSS THE TOP OF THE PACKAGING THAT CAUSED THE PACKAGE TO BE OPENED LEAVING THE SYRINGE NON STERILE. 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. 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 BEFORE USE OF THE BD POSIFLUSH¿ SF SALINE SYRINGE THAT GREEN LIKE TAPE WENT ACROSS THE TOP OF THE PACKAGING THAT CAUSED THE PACKAGE TO BE OPENED LEAVING THE SYRINGE NON STERILE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729269 BD POSIFLUSH¿ SF SALINE SYRINGE SYRINGE NGT BECTON, DICKINSON AND CO. 8150692 30382903065531

    Patients

    Seq Age Sex Outcome Treatment
    1 Other