BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 9718053 · Received February 17, 2020

    Report

    Report Number
    1911916-2020-00157
    Event Type
    Malfunction
    Date Received
    February 17, 2020
    Date of Event
    January 30, 2020
    Report Date
    February 5, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065470
    PMA / PMN Number
    K161552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. 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. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. THIS IS THE 1ST COMPLAINT FOR LOT # 9231536 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE PLUNGER PULLED BACK "TOO FAR" DURING USE, AND THE STOPPER SEPARATED FROM IT, CAUSING BLOOD TO LEAK OUT THE BACK OF THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGE PLUNGER COMES BACK TOO FAR, CAUSING BLOOD TO LEAK OUT OF THE BACK OF THE SYRINGE. USER WAS WEARING APPROPRIATE PPE SO NO EXPOSURE " "IT LOOKS LIKE THE ISSUE WAS ON 1/30. ONE OF OUR TECHNICIANS WAS ACTUALLY USING THE SYRINGE, SO I AM NOT SURE WHY IT PULLED BACK TOO FAR. I DID SEE IT AFTER THE FACT AND IT LOOKED LIKE THE STOPPER WAS CLOSER TO THE END THAN IT SHOULD BE, AND BLOOD WAS DRIPPING OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181928 BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 306547 9231536 30382903065470

    Patients

    Seq Age Sex Outcome Treatment
    1 Other