BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NS FILLED SYRINGE

    MDR report key: 8086106 · Received November 19, 2018

    Report

    Report Number
    9616657-2018-00053
    Event Type
    Malfunction
    Date Received
    November 19, 2018
    Date of Event
    October 31, 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
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIRTEEN 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 THE BD POSIFLUSH NS FILLED SYRINGES WERE "ONLY ALLOWING ABOUT 5ML OF THE 10ML TO BE DISPENSED" DUE TO DIFFICULT PLUNGER MOVEMENT. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    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 THE BD POSIFLUSH¿ NS FILLED SYRINGES WERE "ONLY ALLOWING ABOUT 5ML OF THE 10ML TO BE DISPENSED" DUE TO DIFFICULT PLUNGER MOVEMENT. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924250 BD POSIFLUSH¿ NS FILLED SYRINGE INTRAVASCULAR CATHETER NGT BECTON, DICKINSON AND CO. 7110587 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Other