BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 8121352 · Received November 30, 2018

    Report

    Report Number
    9616657-2018-00058
    Event Type
    Malfunction
    Date Received
    November 30, 2018
    Date of Event
    November 10, 2018
    Report Date
    December 5, 2018
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    K141311
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLE UNITS BELONGING TO LOT NUMBER 7110587 WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. UPON VISUAL INSPECTION OF THE SAMPLES, PLUNGER RESISTANCE WAS IDENTIFIED. A DEVICE HISTORY RECORD REVIEW FOR LOT NUMBER 7110587 REVEALED ONE NON-CONFORMANCE DURING THE PRODUCTION PROCESS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. THERE WAS A RECORDED INTERMITTENT ISSUE WITH THE HOSING IN THE MANUFACTURING MACHINERY AT THE TIME OF THIS LOT'S PRODUCTION. PRODUCT ASSOCIATED WITH THIS DEFECT WAS HELD FOR INSPECTION AND ALL AFFECTED MATERIAL SHOULD HAVE BEEN REJECTED TO SCRAP. IT IS POSSIBLE THAT THE PRODUCT REPORTED WITHIN THIS INCIDENT WENT UNDETECTED. A CORRECTION HAS BEEN MADE TO THE SILICONE SUPPLY HOSING MACHINERY WITHIN THE DESIGNATED FILL ROOM TO PREVENT THIS ISSUE FROM REOCCURRING. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL BE MONITORED BY OUR QUALITY TEAM FOR EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PLUNGER OF BD POSIFLUSH NORMAL SALINE SYRINGE WAS DIFFICULT TO MOVE BEFORE USE.

    Additional Manufacturer Narrative · 1

    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 A PLUNGER OF BD POSIFLUSH¿ NORMAL SALINE SYRINGE WAS DIFFICULT TO MOVE BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961054 BD POSIFLUSH¿ NORMAL SALINE SYRINGE VASCULAR CATHETER FLUSH SYRINGE NGT BECTON, DICKINSON AND CO. 7110587 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Other