BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE¿ CLOSED LUER ACCESS PORT - BNS

    MDR report key: 8712100 · Received June 19, 2019

    Report

    Report Number
    2243072-2019-01211
    Event Type
    Malfunction
    Date Received
    June 19, 2019
    Date of Event
    May 28, 2019
    Report Date
    August 5, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K013621
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED A 3 WAY STOPCOCK WITH 2 Q-SYTES BONDED TO ITS PORTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 7143614, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED TEARS IN THE SLITS OF THE TOP AND BOTTOM SEPTUM DISKS. THE SECOND UNIT ALSO HAS A TEAR IN THE COLUMN WALL. NEXT, A WATER/AIR LEAK TEST WAS PERFORMED ON THE RETURNED UNITS AND NO LEAKAGE WAS OBSERVED COMING FROM THE FIRST UNIT. WITH THE SECOND UNIT LEAKAGE WAS OBSERVED COMING FROM THE TEAR IN THE COLUMN WALL WHEN THE UNIT WAS PLACED INTO THE ACTUATED POSITION. BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. UNFORTUNATELY, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD Q-SYTE¿ CLOSED LUER ACCESS PORT - BNS SALINE LEAKED WHEN INJECTED BY THE SYRINGE FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: SALINE LEAKED WHEN INJECTED BY THE SYRINGE.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD Q-SYTE¿ CLOSED LUER ACCESS PORT - BNS SALINE LEAKED WHEN INJECTED BY THE SYRINGE. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SALINE LEAKED WHEN INJECTED BY THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504277 BD Q-SYTE¿ CLOSED LUER ACCESS PORT - BNS CATHETER FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7143614

    Patients

    Seq Age Sex Outcome Treatment
    1 Other