BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD POSIFLUSH¿ SYRINGE

    MDR report key: 7261308 · Received February 9, 2018

    Report

    Report Number
    1911916-2018-00024
    Event Type
    Injury
    Date Received
    February 9, 2018
    Date of Event
    January 17, 2018
    Report Date
    January 25, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    K161552
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY THIS IS THE FIRST COMPLAINT FOR LOT# 7111693 FOR THE SAME DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH 7111693 DURING THIS PRODUCTION RUN. INVESTIGATION COMMENTS: ALL OUR INSPECTIONS AND TESTING PERFORMED WHILE MANUFACTURING THIS BATCH WERE ACCEPTED. NO REJECTIONS WERE DOCUMENTED. UPDATE (B)(6) 2018. A SAMPLE WAS RECEIVED. THE SYRINGE IS IN THE SEALED PACKAGING FLOW WRAP. THE BARREL LABEL CONFIRMS THE LOT#7111693. IT HAS THE PLUNGER ROD-RUBBER STOPPER, THE TIP CAP AND THE SALINE SOLUTION. THE SAMPLE WILL BE KEPT FOR FUTURE NEEDS, IF ANY. PRODUCT WITHIN SPECIFICATION? YES, NO. ROOT CAUSE COULD NOT BE DETERMINED. THERE WERE NO QNS ISSUED DURING THE PRODUCTION OF THIS BATCH LISTED IN THE COMPLAINT. ALL INSPECTIONS AND TESTING WERE ACCEPTED DURING THE PRODUCTION OF THIS BATCH. UPDATE (B)(6) 2018. TO FURTHER INVESTIGATE BD CHINA MEDICAL AND MARKETING WILL BE ASKED TO GET ADDITIONAL DETAILS ON PATIENT CONDITIONS AND MEDICATIONS AT THE TIME THIS REACTION WAS EXPERIENCED. THIS REPORT WILL BE UPDATED, WHEN MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE, A BD POSIFLUSH¿ SYRINGE WAS GIVEN TO A ¿RADIOTHERAPY PATIENT." THE PATIENT USED A FLUSH AFTER USE OF CHEMOTHERAPEUTICS, THE PATIENT SMELT SOMETHING UNUSUAL, EXPERIENCED NAUSEA, SHAKING, THEN FAINTED. MEDICAL INTERVENTION WAS REQUIRED AS THE PATIENT WAS GIVEN FIRST AID AND EPINEPHRINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105080 BD POSIFLUSH¿ SYRINGE SALINE FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 7111693

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention