BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 ML BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%

    MDR report key: 10022185 · Received May 4, 2020

    Report

    Report Number
    3002682307-2020-00144
    Event Type
    Malfunction
    Date Received
    May 4, 2020
    Date of Event
    April 13, 2020
    Report Date
    May 21, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    NGT
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 9213637 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE PICTURE SAMPLE WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE, THE FLOW WRAP PACKAGING WAS OBSERVED INSUFFICIENTLY SEALED AND TORN. TO FURTHER EVALUATE THIS DEFECT, SIXTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY. THE RETAINED SAMPLES WERE VISUALLY INSPECTED AND NO PACKAGING DEFECTS WERE OBSERVED. IT IS POSSIBLE THAT THIS INCIDENT RESULTED FROM A MISALIGNMENT IN THE PACKAGE SEALING PROCESS. PLEASE NOTE THAT THE FLOW WRAP PACKAGING IS NOT A STERILE BARRIER AND THERE ARE NO ADVERSE HEALTH CONSEQUENCES DUE TO THE OPEN PACKAGES. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE THE PACKAGE IS DISCOVERED TO BE TORN, THUS AFFECTING STERILITY WITH A 5 ML BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TORE SACHET.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. 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 PRIOR TO USE THE PACKAGE IS DISCOVERED TO BE TORN, THUS AFFECTING STERILITY WITH A 5 ML BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TORE SACHET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483655 5 ML BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9% VASCULAR ACCESS FLUSH NGT BECTON DICKINSON, S.A. 9213637

    Patients

    Seq Age Sex Outcome Treatment
    1 Other