BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA CONNECTOR (C35-O)

    MDR report key: 8855585 · Received August 2, 2019

    Report

    Report Number
    2243072-2019-01576
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Date of Event
    July 18, 2019
    Report Date
    September 11, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 1904103, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FIVE 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, ENGAGING AND DISENGAGING THE CONNECTORS AND SAMPLE INJECTORS FROM LOT 1807712. IN ALL CASES THE PRODUCT FUNCTIONED PROPERLY, AND NO ISSUES WERE OBSERVED. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING.

    Additional Manufacturer Narrative · 0

    CORRECTION: PRODUCT GRID UPDATED WITH CAT #, LOT # AND MFR SITE. THE FOLLOWING INFORMATION HAS BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT HAS BEEN REPORTED THAT ONE BD PHASEAL OPTIMA CONNECTOR (C35-O) HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE INJECTOR BECAME DISENGAGED FROM CONNECTOR DURING THE INFUSION. EVENT DESCRIPTION STATES, "PATIENT WAS RECEIVING AN INFUSION. INJECTOR BECAME DISENGAGED FROM CONNECTOR DURING THE INFUSION. POSSIBLE TENSION ON TUBING UPON DISCONNECTION OF CSTD." D.1. MEDICAL DEVICE BRAND NAME: BD PHASEAL OPTIMA CONNECTOR (C35-O). D.2. MEDICAL DEVICE TYPE: ONB. D.2. COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET. D.2. MEDICAL DEVICE CATALOG #: 515070. D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON, S.A. D.4. MEDICAL DEVICE LOT #: 1904103. D.4. MEDICAL DEVICE EXPIRATION DATE: 2020-03-31. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.1. MANUFACTURING LOCATION: BECTON DICKINSON, S.A. H.4. DEVICE MANUFACTURE DATE: 2019-04-29.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE BD PHASEAL OPTIMA CONNECTOR (C35-O) HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE INJECTOR BECAME DISENGAGED FROM CONNECTOR DURING THE INFUSION. EVENT DESCRIPTION STATES, "PATIENT WAS RECEIVING AN INFUSION. INJECTOR BECAME DISENGAGED FROM CONNECTOR DURING THE INFUSION. POSSIBLE TENSION ON TUBING UPON DISCONNECTION OF CSTD."

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE BD PHASEAL OPTIMA CONNECTOR (C35-O) HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE INJECTOR BECAME DISENGAGED FROM CONNECTOR DURING THE INFUSION. EVENT DESCRIPTION STATES, "PATIENT WAS RECEIVING AN INFUSION. INJECTOR BECAME DISENGAGED FROM CONNECTOR DURING THE INFUSION. POSSIBLE TENSION ON TUBING UPON DISCONNECTION OF CSTD."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE UNSPECIFIED BD¿ CLOSED SYSTEM TRANSFER DEVICE HAS BEEN FOUND EXPERIENCING FOUR CASES OF LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN (REPORTED 1904103 WHICH DOES NOT REFERENCE TO A C35-O). IT WAS REPORTED THAT THE INJECTOR BECAME DISENGAGED FROM CONNECTOR DURING THE INFUSION. EVENT DESCRIPTION STATES, "PATIENT WAS RECEIVING AN INFUSION. INJECTOR BECAME DISENGAGED FROM CONNECTOR DURING THE INFUSION. POSSIBLE TENSION ON TUBING UPON DISCONNECTION OF CSTD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648001 BD PHASEAL OPTIMA CONNECTOR (C35-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1904103

    Patients

    Seq Age Sex Outcome Treatment
    1 Other