BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML SALINE 3ML FILL

    MDR report key: 10657204 · Received October 9, 2020

    Report

    Report Number
    1911916-2020-00939
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    June 26, 2020
    Report Date
    September 24, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065449
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER ADDITIONAL PHONE#: (B)(6). INVESTIGATION SUMMARY: "A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 0043481. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS INCIDENT, 1 PHYSICAL SAMPLE AND 2 PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLE, THE SYRINGES HAD NO TIP CAP AND WAS TESTED FOR SUSTAINING FORCE AND THE RESULT WAS WITHIN SPECIFICATION AND THE REPORTED DEFECT WAS NOT OBSERVED. BASED ON THE INVESTIGATION RESULTS, A CAUSE FOR THIS REPORTED INCIDENT COULD NOT BE IDENTIFIED. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE MANUFACTURING PROCESS FOR THIS DEFECT AND OTHER EMERGING TRENDS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE BD SALINE VASCULAR ACCESS FLUSH HAD DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT STAFF IS HAVING ISSUES PRIMING/FLUSHING. PER ATTACHED NOTE ON BAG: TRIFURCATE NOT FLUSHING HAD TO GO THROUGH COUPLE BEFORE ONE WORKED. PLEASE ADVISE WHAT ADDITIONAL INFORMATION IS NEEDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124345 SYRINGE 3ML SALINE 3ML FILL SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 306544 0043481 30382903065449

    Patients

    Seq Age Sex Outcome Treatment
    1 Other