BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 7630131 · Received June 22, 2018

    Report

    Report Number
    1911916-2018-00312
    Event Type
    Malfunction
    Date Received
    June 22, 2018
    Date of Event
    May 28, 2018
    Report Date
    August 23, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    00382903065462
    PMA / PMN Number
    K141311
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: DEVICE RETURNED TO MANUFACTURE: YES.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO SAMPLES WERE RECEIVED FOR EVALUATION BY ONE OF OUR QUALITY ENGINEERS. THE TWO (2) SAMPLES RECEIVED HAVE NO PACKAGING FLOW WRAP. THEY DO HAVE THE PLUNGER ROD-RUBBER STOPPER, THE TIP CAP AND SALINE SOLUTION. THE BARREL LABEL CONFIRMS THE LOT# 8050995. PRESSURE WAS PUT ON THE PLUNGER ROD NOT NOTICING ANY LEAKAGE; BOTH SAMPLES WERE INSPECTED FINDING NO ISSUES THEREFORE FAILURE MODE IS NOT VERIFIED AND ROOT CAUSE COULD NOT BE DETERMINED. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF LEAKAGE PAST STOPPER WITH LOT #8050995, REGARDING ITEM #306546. THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH 8050995 DURING THIS PRODUCTION RUN. INVESTIGATION CONCLUSION: UNABLE TO DETERMINE A ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE WAS "LEAKING FROM THE BACK END OF SEAL WHEN PRESSURE WAS APPLIED TO THE PLUNGER¿. FOUND DURING USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE WAS "LEAKING FROM THE BACK END OF SEAL WHEN PRESSURE WAS APPLIED TO THE PLUNGER¿. FOUND DURING USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    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 THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE WAS "LEAKING FROM THE BACK END OF SEAL WHEN PRESSURE WAS APPLIED TO THE PLUNGER¿. FOUND DURING USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473876 BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE FLUSH SYRINGE NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 8050995 00382903065462

    Patients

    Seq Age Sex Outcome Treatment
    1 Other