BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA CONNECTOR (C35-O)

    MDR report key: 8884760 · Received August 12, 2019

    Report

    Report Number
    2243072-2019-01677
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    July 24, 2019
    Report Date
    September 11, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    K181221
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DESCRIPTION, MEDICAL DEVICE BRAND NAME, COMMON DEVICE NAME, MEDICAL DEVICE TYPE, DEVICE MANUFACTURER, DEVICE EXPIRATION DATE, DEVICE MANUFACTURE DATE, UNIQUE IDENTIFIER NUMBER, PMA/510(K)#, AND DEVICE MANUFACTURE DATE HAVE BEEN UPDATED. THE FOLLOWING INFORMATION HAS BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD PHASEAL OPTIMA CONNECTOR (C35-O) EXPERIENCED A LOOSE CONNECTOR OR SEPARATION OF CONNECTOR AND INJECTOR DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515070, BATCH NO: 1904103 EVENT DESCRIPTION STATED: PATIENT WAS RECEIVING A 24HR INFUSION ON AN IP UNIT. INFUSION DISCONNECTED AT THE CONNECTOR/INJECTOR CONNECTION CLOSE TO THE 24HR MARK. NO LEAK OCCURRED, AND NO PATIENT OR NURSE INJURY. D.1. MEDICAL DEVICE BRAND NAME: BD PHASEAL OPTIMA CONNECTOR (C35-O), D.1. COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET, D.2. MEDICAL DEVICE TYPE: ONB, D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON, S.A., SAN AGUSTIN, D.4. MEDICAL DEVICE BRAND NAME: BD PHASEAL OPTIMA CONNECTOR (C35-O), D.4. COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET, D.4. MEDICAL DEVICE EXPIRATION DATE: 2020-03-31, D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4), G.1. MANUFACTURING LOCATION: BECTON DICKINSON, S.A., SAN AGUSTIN, G.5. PMA/510(K)#: K181221, H.4. DEVICE MANUFACTURE DATE: 2019-04-29 H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    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. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL OPTIMA CONNECTOR (C35-O) EXPERIENCED A LOOSE CONNECTOR OR SEPARATION OF CONNECTOR AND INJECTOR DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515070, BATCH NO: 1904103. EVENT DESCRIPTION STATED: PATIENT WAS RECEIVING A 24HR INFUSION ON AN IP UNIT. INFUSION DISCONNECTED AT THE CONNECTOR/INJECTOR CONNECTION CLOSE TO THE 24HR MARK. NO LEAK OCCURRED, AND NO PATIENT OR NURSE INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL OPTIMA CONNECTOR (C35-O) EXPERIENCED A LOOSE CONNECTOR OR SEPARATION OF CONNECTOR AND INJECTOR DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515070, BATCH NO: 1904103. EVENT DESCRIPTION STATED: PATIENT WAS RECEIVING A 24HR INFUSION ON AN IP UNIT. INFUSION DISCONNECTED AT THE CONNECTOR/INJECTOR CONNECTION CLOSE TO THE 24HR MARK. NO LEAK OCCURRED, AND NO PATIENT OR NURSE INJURY.

    Additional Manufacturer Narrative · 1

    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. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD CATHETER EXPERIENCED A LOOSE CONNECTOR OR SEPARATION OF CONNECTOR AND INJECTOR DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN, BATCH NO: UNKNOWN. EVENT DESCRIPTION STATED: PATIENT WAS RECEIVING A 24HR INFUSION ON AN IP UNIT. INFUSION DISCONNECTED AT THE CONNECTOR/INJECTOR CONNECTION CLOSE TO THE 24 HR MARK. NO LEAK OCCURRED, AND NO PATIENT OR NURSE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676736 BD PHASEAL OPTIMA CONNECTOR (C35-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1904103

    Patients

    Seq Age Sex Outcome Treatment
    1 Other