BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA CONNECTOR

    MDR report key: 12512066 · Received September 22, 2021

    Report

    Report Number
    3003152976-2021-00624
    Event Type
    Malfunction
    Date Received
    September 22, 2021
    Date of Event
    August 26, 2021
    Report Date
    November 4, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150708
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 2011504. D4: MEDICAL DEVICE EXPIRATION DATE: 2022-01-31. H4: DEVICE MANUFACTURE DATE: 2020-11-20. D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-11-03. H6: INVESTIGATION SUMMARY: TWO UNUSED SAMPLES RECEIVED FOR INVESTIGATION, ONE OPTIMA INJECTOR AND ONE OPTIMA CONNECTOR. UPON A VISUAL INSPECTION, NO DAMAGES OR ANOMALIES WERE OBSERVED ON THE SAMPLES. NINE RETAINED SAMPLES FROM THE SAME LOTS WERE EVALUATED, AND LUER LOCK MEASURED, NO DAMAGE OR DEFECTS OBSERVED, MEASUREMENTS MET ACCEPTANCE CRITERIA. THE PRODUCT WAS VISUALLY INSPECTED AND NO DEFECTS WERE IDENTIFIED. FUNCTIONAL TESTING WAS PERFORMED, CONNECTING THE INJECTOR TO A SAMPLE SYRINGE, PROTECTOR AND VIAL ACCORDING TO THE INSTRUCTIONS FOR USE. IN ALL CASES THE PRODUCT FUNCTIONED PROPERLY, AND NO ISSUES WERE OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. BASED ON THE VARIOUS TESTS WHERE THE OPTIMA INJECTORS N40-O AND OPTIMA CONNECTORS ARE LUER CONNECTED TO DIFFERENT MATTING COMPONENTS OVER MULTIPLE PENETRATIONS, AND ENGAGED/DISENGAGEMENT TEST WERE PERFORMED, IF ANY INCIDENT RELATED TO THE FAILURE HAVE OCCURRED IT WOULD HAVE BEEN DETECTED. PRODUCT UNDERGOES A SERIES OF INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING FLOW RATE VERIFICATION. FUNCTIONAL TESTING WAS PERFORMED, PENETRATING THE INJECTOR ALONG WITH A SAMPLE SYRINGE AND MATING COMPONENTS TEN TIMES, ALL RESULTS WERE FOUND TO BE ACCEPTABLE WITH NO LEAKS IDENTIFIED. IT SHOULD BE CONSIDERED THAT INJECTOR/CONNECTOR SEPARATION FAILURE MODE IS A DRY DISCONNECT WHICH PREVENTS LEAKAGE BY DESIGN. IT IS RECOMMENDED TO USE THE OPTIONAL M25-O CLAMP TO AVOID DRY DISCONNECTS DURING USE. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. H3 OTHER TEXT: SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED TWO BD PHASEAL OPTIMA CONNECTORS HAD A LOOSE INJECTOR/SEPARATION OF INJECTOR AND MATING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RN ENTERED PATIENT ROOM TO TROUBLESHOOT AND OBSERVED THAT THE CLOSED SYSTEM TRANSFER DEVICE HAD BECOME DISCONNECTED BETWEEN THE INJECTOR AND CONNECTOR PORTIONS. BOTH PORTIONS OF IT WERE STILL SECURED ON PATIENT LINE AND END OF IV LINE. RN CLEANED THE CONNECTOR PORTION AND REATTACHED SECURELY AND TAPED CONNECTION (INFUSION CLAMP WAS NOT USED). APPROX 60 MINUTES LATER ABOUT AN HOUR LATER THE PUMP RANG DOWNSTREAM OCCLUSION AGAIN AND THE CONNECTOR/INJECTOR WAS AGAIN DISCONNECTED DESPITE BEING TAPED."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED TWO BD PHASEAL OPTIMA CONNECTORS HAD A LOOSE INJECTOR/SEPARATION OF INJECTOR AND MATING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RN ENTERED PATIENT ROOM TO TROUBLESHOOT AND OBSERVED THAT THE CLOSED SYSTEM TRANSFER DEVICE HAD BECOME DISCONNECTED BETWEEN THE INJECTOR AND CONNECTOR PORTIONS. BOTH PORTIONS OF IT WERE STILL SECURED ON PATIENT LINE AND END OF IV LINE. RN CLEANED THE CONNECTOR PORTION AND REATTACHED SECURELY AND TAPED CONNECTION (INFUSION CLAMP WAS NOT USED). APPROX 60 MINUTES LATER ABOUT AN HOUR LATER THE PUMP RANG DOWNSTREAM OCCLUSION AGAIN AND THE CONNECTOR/INJECTOR WAS AGAIN DISCONNECTED DESPITE BEING TAPED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1410277 BD PHASEAL OPTIMA CONNECTOR INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2011504 00382905150708

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown