BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL CONNECTOR LUER LOCK (C35)

    MDR report key: 10052340 · Received May 13, 2020

    Report

    Report Number
    3003152976-2020-00203
    Event Type
    Malfunction
    Date Received
    May 13, 2020
    Date of Event
    March 24, 2020
    Report Date
    June 26, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905152000
    PMA / PMN Number
    K123213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY NO PHOTOS OR SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1905113, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THREE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED AND NO DEFECTS WERE IDENTIFIED. FUNCTIONAL TESTING WAS PERFORMED, PROPERLY CONNECTING A SAMPLE SYRINGE AND INJECTOR ONTO THE RETAINED CONNECTOR SAMPLES. THE INJECTOR WAS DISENGAGED AND THE PROCESS WAS REPEATED FIVE TIMES, IN ALL CASES THE PRODUCT FUNCTIONED PROPERLY, AND NO ISSUES WERE OBSERVED. PRODUCT UNDERGOES VISUAL AND FUNCTIONAL TESTING THROUGHOUT MANUFACTURING TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. IT IS IMPORTANT TO FOLLOW THE INSTRUCTIONS FOR USE WHEN USING PHASEAL DEVICES TO ENSURE THE PRODUCT FUNCTIONS PROPERLY. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.6. CORRECTION: NEW GUIDELINES HAVE BEEN ISSUED STATING: WHEN THE CONNECTOR IS NOT ABLE TO OR DIFFICULT TO CONNECT TO THE INJECTOR, THIS MAY LEAD TO CUSTOMER DISSATISFACTION AS A NEW CONNECTOR IS REQUIRED BUT DOES NOT LEAD TO ANY DEGREE OF HARM/SERIOUS INJURY. THE NEW GUIDELINES SUPERSEDE PREVIOUS MDR. DUE TO THIS NEW INFORMATION THIS EVENT IS NO LONGER REPORTABLE AS A MALFUNCTION. THIS EVENT WAS OVER REPORTED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PHASEAL¿ CONNECTOR LUER LOCK (C35) DOES NOT FIT. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DOXORUBICIN ADAPTER DOES NOT FIT TO INJECT THE CHEMOTHERAPY PRODUCT. THE ADAPTER WAS DISCARDED. FOR SOME TIME, NURSES HAVE BEEN EXPERIENCING DIFFICULTIES IN CORRECTLY ADAPTING THE CONNECTOR C35 PHASEAL TO THE INJECTOR N35, MAKING ITS USE IMPOSSIBLE. NURSES ARE THEREFORE OBLIGED TO REMOVE THE INJECTOR (WHICH IS ADAPTED BY THE PHARMACY WHEN THE SYRINGE IS RECONSTITUTED), RISKING EXPOSURE TO THE CHEMOTHERAPY PRODUCT CONTAINED IN THE SYRINGE. IN THE CASE CITED IN THIS STATEMENT, THE NURSE REMOVED THE INJECTOR TO DISPENSE THE PRODUCT. THE PATIENT COMPLETED THE ENTIRE COURSE OF TREATMENT. THE SYRINGE ASSEMBLY, CONNECTOR AND INJECTOR HAVE NOT BEEN KEPT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PHASEAL¿ CONNECTOR LUER LOCK (C35) DOES NOT FIT. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DOXORUBICIN ADAPTER DOES NOT FIT TO INJECT THE CHEMOTHERAPY PRODUCT. THE ADAPTER WAS DISCARDED. FOR SOME TIME, NURSES HAVE BEEN EXPERIENCING DIFFICULTIES IN CORRECTLY ADAPTING THE CONNECTOR C35 PHASEAL TO THE INJECTOR N35, MAKING ITS USE IMPOSSIBLE. NURSES ARE THEREFORE OBLIGED TO REMOVE THE INJECTOR (WHICH IS ADAPTED BY THE PHARMACY WHEN THE SYRINGE IS RECONSTITUTED), RISKING EXPOSURE TO THE CHEMOTHERAPY PRODUCT CONTAINED IN THE SYRINGE. IN THE CASE CITED IN THIS STATEMENT, THE NURSE REMOVED THE INJECTOR TO DISPENSE THE PRODUCT. THE PATIENT COMPLETED THE ENTIRE COURSE OF TREATMENT. THE SYRINGE ASSEMBLY, CONNECTOR AND INJECTOR HAVE NOT BEEN KEPT.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). 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) DOES NOT FIT. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DOXORUBICIN ADAPTER DOES NOT FIT TO INJECT THE CHEMOTHERAPY PRODUCT. THE ADAPTER WAS DISCARDED. FOR SOME TIME, NURSES HAVE BEEN EXPERIENCING DIFFICULTIES IN CORRECTLY ADAPTING THE CONNECTOR C35 PHASEAL TO THE INJECTOR N35, MAKING ITS USE IMPOSSIBLE. NURSES ARE THEREFORE OBLIGED TO REMOVE THE INJECTOR (WHICH IS ADAPTED BY THE PHARMACY WHEN THE SYRINGE IS RECONSTITUTED), RISKING EXPOSURE TO THE CHEMOTHERAPY PRODUCT CONTAINED IN THE SYRINGE. IN THE CASE CITED IN THIS STATEMENT, THE NURSE REMOVED THE INJECTOR TO DISPENSE THE PRODUCT. THE PATIENT COMPLETED THE ENTIRE COURSE OF TREATMENT. THE SYRINGE ASSEMBLY, CONNECTOR AND INJECTOR HAVE NOT BEEN KEPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517944 BD PHASEAL CONNECTOR LUER LOCK (C35) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515200 1905113 30382905152000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other