BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 7593995 · Received June 12, 2018

    Report

    Report Number
    1911916-2018-00270
    Event Type
    Malfunction
    Date Received
    June 12, 2018
    Date of Event
    May 20, 2018
    Report Date
    June 12, 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 · 1

    INITIAL REPORTER ADDRESS: (B)(6). SUMMARY: FOUR (4) SAMPLES WERE RECEIVED FOR EVALUATION BY ONE OF OUR QUALITY ENGINEERS. THEY ALL ARE IN THE PACKAGING FLOW WRAP, HAVE THE PLUNGER ROD-RUBBER STOPPER, THE TIP CAP AND SALINE SOLUTION. THE BARREL LABEL CONFIRMS THE LOT# 7241671. ALL HAVE THE BARREL/FLANGE DAMAGED THEREFORE FAILURE MODE IS VERIFIED. THE PLUNGER ROD LABELER EQUIPMENT POSSIBLY EXPERIENCED A VARIATION HOWEVER ADJUSTMENTS HAVE BEEN MADE AND VERIFIED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. A DEVICE HISTORY REVIEW WAS COMPLETED AND THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH 7241671 DURING THIS PRODUCTION RUN. THERE WERE NO QUALITY NOTIFICATION ISSUED DURING THE PRODUCTION OF THIS BATCH LISTED IN THE COMPLAINT. ALL INSPECTIONS AND TESTING WERE ACCEPTED DURING THE PRODUCTION OF THIS BATCH. CAPA (B)(4) HAS BEEN OPENED. CONCLUSION: ALL OUR INSPECTIONS PERFORMED WHILE MANUFACTURING THIS BATCH WERE ACCEPTED; NO REJECTIONS WERE DOCUMENTED. UPDATE JUNE 04, 2018. FOUR (4) SAMPLES WERE RECEIVED. THEY ALL ARE IN THE PACKAGING FLOW WRAP, HAVE THE PLUNGER ROD-RUBBER STOPPER, THE TIP CAP AND SALINE SOLUTION. THE BARREL LABEL CONFIRMS THE LOT# 7241671. ALL HAVE THE BARREL/FLANGE DAMAGED. PRODUCT WITHIN SPECIFICATION? YES? NO? ROOT CAUSE: ROOT CAUSE COULD NOT BE DETERMINED. THERE WERE NO QNS 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 / LEAKAGE. THE PLUNGER ROD LABELER EQUIPMENT POSSIBLE EXPERIENCED A VARIATION; ANYWAY, ADJUSTMENTS HAVE BEEN VERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE FOUND THE BROKEN FLANGE ON A 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE AFTER OPENING THE UNIT PACKAGE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436431 BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 7241671

    Patients

    Seq Age Sex Outcome Treatment
    1 Other