BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA INJECTOR (N35-O)

    MDR report key: 8857401 · Received August 2, 2019

    Report

    Report Number
    2243072-2019-01587
    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
    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 4 BD PHASEAL OPTIMA INJECTORS (N35-O) EXPERIENCED A LOOSE CONNECTOR OR A SEPARATION BETWEEN CONNECTOR AND INJECTOR DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515052; BATCH NO: 1807712. EVENT DESCRIPTION: PATIENT WAS RECEIVING AN INFUSION. INJECTOR BECAME DISENGAGED FROM CONNECTOR DURING THE INFUSION. POSSIBLE TENSION ON TUBING UPON DISCONNECTION. D.1. MEDICAL DEVICE BRAND NAME: BD PHASEAL OPTIMA INJECTOR (N35-O); D.1. COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET; D.2. MEDICAL DEVICE TYPE: ONB; D.4. MEDICAL DEVICE CATALOG #: 515052; D.4. MEDICAL DEVICE LOT #: 1807712; D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON, S.A., SAN AGUSTIN; D.4. MEDICAL DEVICE EXPIRATION DATE: 2019-12-31; 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: 2018-07-19; H3 OTHER TEXT : SEE H.10.

    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 1807712, 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 INJECTOR AND A SAMPLE CONNECTOR FROM LOT 1904103. 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 TRENDS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD PHASEAL OPTIMA INJECTORS (N35-O) EXPERIENCED A LOOSE CONNECTOR OR A SEPARATION BETWEEN CONNECTOR AND INJECTOR DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515052; BATCH NO: 1807712. EVENT DESCRIPTION: PATIENT WAS RECEIVING AN INFUSION. INJECTOR BECAME DISENGAGED FROM CONNECTOR DURING THE INFUSION. POSSIBLE TENSION ON TUBING UPON DISCONNECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD PHASEAL OPTIMA INJECTORS (N35-O) EXPERIENCED A LOOSE CONNECTOR OR A SEPARATION BETWEEN CONNECTOR AND INJECTOR DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515052, BATCH NO: 1807712. EVENT DESCRIPTION: PATIENT WAS RECEIVING AN INFUSION. INJECTOR BECAME DISENGAGED FROM CONNECTOR DURING THE INFUSION. POSSIBLE TENSION ON TUBING UPON DISCONNECTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 4 UNSPECIFIED BD CONNECTOR DEVICES EXPERIENCED A LOOSE CONNECTOR OR A SEPARATION BETWEEN CONNECTOR AND INJECTOR DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN, BATCH NO: UNKNOWN. EVENT DESCRIPTION: PATIENT WAS RECEIVING AN INFUSION. INJECTOR BECAME DISENGAGED FROM CONNECTOR DURING THE INFUSION. POSSIBLE TENSION ON TUBING UPON DISCONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647791 BD PHASEAL OPTIMA INJECTOR (N35-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1807712

    Patients

    Seq Age Sex Outcome Treatment
    1 Other