BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ SF SALINE SYRINGE

    MDR report key: 9290247 · Received November 7, 2019

    Report

    Report Number
    1911916-2019-01165
    Event Type
    Malfunction
    Date Received
    November 7, 2019
    Date of Event
    October 13, 2019
    Report Date
    October 22, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    00382903064991
    PMA / PMN Number
    K161552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE SAMPLE WAS RECEIVED. IT CAME IN A PLASTIC ZIPLOC BAG WITH NO PACKAGING FLOW WRAP. IT HAS THE PLUNGER ROD-RUBBER STOPPER, NO TIP CAP, AND 4.5 ML OF SOLUTION. THE BARREL LABEL CONFIRMS THE LOT#. IT CAME WITH A 3 WAY CONNECTOR. ONE OF THE CONNECTIONS HAS THE LUER TIP THAT BROKE OFF. THIS DEFECT WAS REPRODUCED BY CONNECTING THE 3 WAY CONNECTOR TO A SYRINGE. OVER TIGHTENING THE SYRINGE BREAKS THE LUER TIP. NO MANUFACTURING ISSUES WERE EXPERIENCED DURING THE PRODUCTION OF THESE PRODUCTS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. INVESTIGATION CONCLUSION: 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. ROOT CAUSE DESCRIPTION: ROOT CAUSE OVERTIGHT WHEN USE. RATIONALE: NO MANUFACTURING ISSUES WERE EXPERIENCED DURING THE PRODUCTION OF THESE PRODUCTS. THE SYMPTOM CAN BE REPRODUCED BY OVER TIGHTENING THE SYRINGE TO THE 3 WAY CONNECTOR.

    Description of Event or Problem · 1

    MATERIAL NO.: 306499 BATCH NO.: 9002664. IT WAS REPORTED THAT DURING USE OF THE BD POSIFLUSH¿ SF SALINE SYRINGE THE SYRINGE TIP BROKE OFF IN THE STOP COCK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿SYRINGE TIP BROKE OFF IN THE STOP COCK. I DON¿T THINK IT HAD ANYTHING TO DO WITH THE AMOUNT OF FORCE I WAS USING, NO MORE FORCE USED THAN NORMAL. THIS OCCURRED AFTER THE ARTERIAL LINE CHANGE AND WHEN WE WENT TO REMOVE THE SYRINGE FROM THE STOPCOCK AFTER DRAWING LABS ON AN OPEN SYSTEM ARTERIAL LINE. I WENT TO EXCHANGE THE SYRINGE TO PUT AN EMPTY ONE ON TO DRAW MY LABS. WHEN TWISTING OFF THE FULL NS SYRINGE THE TIP BROKE OFF. I WAS NOT DRAWING BACK AT THE TIME SIMPLY TWISTING OFF THE SYRINGE. HOPE THIS HELPS. I HAVE AN ARTERIAL LINE FREQUENTLY AND THIS HAD NEVER HAPPENED BEFORE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083366 BD POSIFLUSH¿ SF SALINE SYRINGE INTRAVASCULAR CATHETER NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 9002664 00382903064991

    Patients

    Seq Age Sex Outcome Treatment
    1 Other