BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ OPTIMA SYSTEM, INJECTOR, N35-O

    MDR report key: 8855224 · Received August 2, 2019

    Report

    Report Number
    2243072-2019-01571
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Date of Event
    July 18, 2019
    Report Date
    September 10, 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

    CORRECTION: ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. THE FOLLOWING FIELDS HAVE BEEN UPDATED: B.4.MATERIAL NO: 515052; BATCH NO: 1807712. IT WAS REPORTED THAT DURING USE OF THE BD PHASEAL¿ OPTIMA SYSTEM, INJECTOR, N35-O THE INJECTOR BECAME DISENGAGED FROM CONNECTOR DURING THE INFUSION. THIS OCCURRED ON 4 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "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 INJECTOR (N35-O). D.2. COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET. D.2. MEDICAL DEVICE TYPE: ONB. D.2. MEDICAL DEVICE CATALOG#: 515052. D.2. MEDICAL DEVICE LOT#: 1807712. D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON, S.A. D.4. MEDICAL DEVICE EXPIRATION DATE: 2019-12-31. D.5. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.2. MANUFACTURING LOCATION: BECTON DICKINSON, S.A. G.5. PMA / 510(K)#: K181221. H.4. DEVICE MANUFACTURE DATE: 2018-07-19 H3 OTHER TEXT : SEE SECTION H.10.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    MATERIAL NO: 515052; BATCH NO: 1807712. IT WAS REPORTED THAT DURING USE OF THE BD PHASEAL¿ OPTIMA SYSTEM, INJECTOR, N35-O THE INJECTOR BECAME DISENGAGED FROM CONNECTOR DURING THE INFUSION. THIS OCCURRED ON 4 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "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

    MATERIAL NO: 515052, BATCH NO: 1807712. IT WAS REPORTED THAT DURING USE OF THE BD PHASEAL¿ OPTIMA SYSTEM, INJECTOR, N35-O THE INJECTOR BECAME DISENGAGED FROM CONNECTOR DURING THE INFUSION. THIS OCCURRED ON 4 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "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

    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). 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 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

    MATERIAL NO: UNKNOWN, BATCH NO: UNKNOWN. IT WAS REPORTED THAT DURING USE OF THE UNSPECIFIED BD PHASEAL¿ SYRINGE SAFETY DEVICE THE INJECTOR BECAME DISENGAGED FROM CONNECTOR DURING THE INFUSION. THIS OCCURRED ON 4 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "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
    648034 BD PHASEAL¿ OPTIMA SYSTEM, INJECTOR, N35-O INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1807712

    Patients

    Seq Age Sex Outcome Treatment
    1 Other