BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 7620672 · Received June 20, 2018

    Report

    Report Number
    1911916-2018-00320
    Event Type
    Malfunction
    Date Received
    June 20, 2018
    Date of Event
    June 6, 2018
    Report Date
    June 26, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    K161552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: FOUR (4) SAMPLES WERE RECEIVED FOR EVALUATION BY ONE OF OUR QUALITY ENGINEERS. TWO (2) ARE IN THE PACKAGING FLOW WRAP. ALL FOUR (4) HAVE THE PLUNGER ROD-RUBBER STOPPER AND THE TIP CAP. TWO (2) HAVE SALINE SOLUTION. THE BARREL LABEL CONFIRMS THE LOT# 7241671. ALL FOUR (4) HAVE THE BARREL/FLANGE DAMAGED THEREFORE FAILURE MODE IS VERIFIED. IT IS POSSIBLE THAT THE PLUNGER ROD LABELER EQUIPMENT EXPERIENCED A VARIATION. ADJUSTMENTS HAVE BEEN MADE. A DEVICE HISTORY REVIEW WAS COMPLETED AND THERE WERE NO DOCUMENTED ISSUES FOR THE COMPLAINT OF BATCH 7241671 DURING THIS PRODUCTION RUN. THERE WERE NO QUALITY NOTIFICATIONS WERE ISSUED DURING THE PRODUCTION OF THIS BATCH LISTED IN THE COMPLAINT. ALL INSPECTIONS WERE ACCEPTED DURING THE PRODUCTION OF THIS BATCH. THERE WAS NO ISSUE DOCUMENTED ABOUT BARREL/FLANGE DAMAGED. THE PLUNGER ROD LABELER EQUIPMENT POSSIBLY EXPERIENCED A VARIATION WHICH COULD POTENTIALLY CAUSE THE ISSUE. CAPA 390709 (CORRECTIVE ACTION PREVENTIVE ACTION) HAS BEEN INITIATED TO ADDRESS THIS ISSUE.

    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 WITH THE USE OF THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE THERE WAS AN ISSUE WITH A POTENTIAL INJURY. IT WAS STATED ¿THE NURSE FOUND THE FLANGE BROKEN WHEN OPENED THE UNIT PACKAGE.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465398 BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 7241671

    Patients

    Seq Age Sex Outcome Treatment
    1 Other