BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ OPTIMA SYSTEM, INJECTOR, N35-O

    MDR report key: 8860152 · Received August 5, 2019

    Report

    Report Number
    2243072-2019-01603
    Event Type
    Malfunction
    Date Received
    August 5, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: SITE LEGAL NAME (FDA): BECTON DICKINSON, S.A. - SAN AGUSTIN DE GUADALIX, SPAIN / 28750. MEDICAL DEVICE BRAND NAME: BD PHASEAL¿ OPTIMA SYSTEM, INJECTOR, N35-O. COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET. MEDICAL DEVICE MANUFACTURER: SAN AGUSTIN. MEDICAL DEVICE CATALOG #: 515052. MEDICAL DEVICE EXPIRATION DATE: 2019-12-31. MEDICAL DEVICE LOT #: 1807712. UNIQUE IDENTIFIER (UDI) #: (B)(4). MANUFACTURING LOCATION: SAN AGUSTIN. PMA/510(K)#: K181221. DEVICE MANUFACTURE DATE: 2018-07-19.

    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 BD PHASEAL¿ OPTIMA SYSTEM, INJECTOR, N35-O BECAME DISENGAGED FROM THE CONNECTOR. THIS OCCURRED ON 4 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515052 BATCH NO: 1807712. IT WAS REPORTED THAT THE INJECTOR BECAME DISENGAGED FROM CONNECTOR DURING THE INFUSION. 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 WAS REPORTED THAT BD PHASEAL¿ OPTIMA SYSTEM, INJECTOR, N35-O BECAME DISENGAGED FROM THE CONNECTOR. THIS OCCURRED ON 4 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515052 BATCH NO: 1807712. IT WAS REPORTED THAT THE INJECTOR BECAME DISENGAGED FROM CONNECTOR DURING THE INFUSION. 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. 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. (B)(4). 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 WAS REPORTED THAT UNSPECIFIED BD¿ INJECTOR BECAME DISENGAGED FROM THE CONNECTOR. THIS OCCURRED ON 4 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN IT WAS REPORTED THAT THE INJECTOR BECAME DISENGAGED FROM CONNECTOR DURING THE INFUSION. 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
    656939 BD PHASEAL¿ OPTIMA SYSTEM, INJECTOR, N35-O INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1807712

    Patients

    Seq Age Sex Outcome Treatment
    1 Other