BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL CONNECTOR LUER LOCK (C35)

    MDR report key: 9759160 · Received February 26, 2020

    Report

    Report Number
    3003152976-2020-00085
    Event Type
    Malfunction
    Date Received
    February 26, 2020
    Date of Event
    February 6, 2020
    Report Date
    April 14, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905152000
    PMA / PMN Number
    K123213
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY : ONE SAMPLE UNIT WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE CONNECTOR RECEIVED WAS CONNECTED TO A LUER LOCK CONNECTION FROM AN INFUSION SET C80 FROM LOT 1905101 AND THEN TO AN INJECTOR LOT 0066022+ SYRINGE (WITH GREEN COLORANT). UPON VISUAL INSPECTION OF THE SAMPLE, NO DEFECTS WERE OBSERVED ON THE CONNECTOR. FUNCTIONAL TESTING WAS PERFORMED, CONNECTING THE SAMPLE TO LUER LOCK CONNECTION FOR AN INFUSION SET AND A SAMPLE INJECTOR AND SYRINGE. LIQUID WAS ABLE TO PASS FROM THE SYRINGE THOUGH THE INJECTOR AND CONNECTOR, AND INTO THE TUBING SET WITHOUT ISSUE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1910112. NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PHASEAL¿ CONNECTOR LUER LOCK (C35) DID NOT ALLOW INJECTION. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPDATE AFTER ASKING IF THE DEFECT IS CLOG: THE PROBLEM WAS, THAT THERE WAS NO ACCESS. THE PHASEAL LUER LOCK CONNECTOR (C35) DID NOT ALLOW ANY INJECTION, AFTER CONNECTED TO THE INJECTOR. THE PHASEAL CONNECTOR AND THE PHASEAL INJECTOR WAS THEREFORE TAKEN OFF, AND THE INJECTION WAS GIVEN WITHOUT THE PROJECTION FROM THE PHASEAL DEVICES.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PHASEAL¿ CONNECTOR LUER LOCK (C35) DID NOT ALLOW INJECTION. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPDATE AFTER ASKING IF THE DEFECT IS CLOG: THE PROBLEM WAS, THAT THERE WAS NO ACCESS. THE PHASEAL LUER LOCK CONNECTOR (C35) DID NOT ALLOW ANY INJECTION, AFTER CONNECTED TO THE INJECTOR. THE PHASEAL CONNECTOR AND THE PHASEAL INJECTOR WAS THEREFORE TAKEN OFF, AND THE INJECTION WAS GIVEN WITHOUT THE PROJECTION FROM THE PHASEAL DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223401 BD PHASEAL CONNECTOR LUER LOCK (C35) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515200 1910112 30382905152000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other