BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA INJECTOR (N40-O)

    MDR report key: 12020897 · Received June 17, 2021

    Report

    Report Number
    3003152976-2021-00330
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 20, 2021
    Report Date
    July 8, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150562
    PMA / PMN Number
    K201099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D4: MEDICAL DEVICE LOT #: 2103306. D4: MEDICAL DEVICE EXPIRATION DATE: 2022-05-31. H4: DEVICE MANUFACTURE DATE: 2021-03-29. D4: MEDICAL DEVICE LOT #: 2012310. D4: MEDICAL DEVICE EXPIRATION DATE: 2022-02-28. H4: DEVICE MANUFACTURE DATE: 2020-12-21. H6: INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR SUSPECTED LOTS 2012310 AND 2103306, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS, INCLUDING TESTING TO VERIFY ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION SUCH AS THE LUER THREADING. ALL RECORDS WERE REVIEWED FOR THE REPORTED LOT AND RESULTS WERE FOUND TO BE ACCEPTABLE. THREE RETAINED SAMPLES FROM LOT 2012310 AND THREE FROM LOT 2103306 WERE INSPECTED, NO DAMAGE WAS OBSERVED ON THE PRODUCT AND ALL LUER DIMENSIONS WERE VERIFIED TO BE WITHIN THE REQUIRED SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. IT IS IMPORTANT TO ENSURE ALL LUER CONNECTIONS ARE SECURELY TIGHTENED BEFORE USE. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA INJECTOR (N40-O) SEPARATED FROM THE 5FU HOME INFUSION PUMP DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THEIR OUTPATIENT INFUSION CENTER HAD A DISCONNECT UTILIZING THE BD PHASEAL OPTIMA LOCKING INJECTOR". "THE LOCKING INJECTOR WAS USED ON A 5FU HOME INFUSION PUMP. WHILE IN THE BLUE CLAMP PIECE AND CONNECTED TO THE CONNECTOR, THE INJECTOR IS REPORTED BY THE PATIENT TO HAVE UN-LUERED. THERE WAS SOME 5FU THAT WAS REPORTED TO HAVE COME OUT OF THE BAG, BUT THE PATIENT WAS ABLE TO LUER THE LOCKING INJECTOR BACK ON."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA INJECTOR (N40-O) SEPARATED FROM THE 5FU HOME INFUSION PUMP DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THEIR OUTPATIENT INFUSION CENTER HAD A DISCONNECT UTILIZING THE BD PHASEAL OPTIMA LOCKING INJECTOR" "THE LOCKING INJECTOR WAS USED ON A 5FU HOME INFUSION PUMP. WHILE IN THE BLUE CLAMP PIECE AND CONNECTED TO THE CONNECTOR, THE INJECTOR IS REPORTED BY THE PATIENT TO HAVE UN-LUERED. THERE WAS SOME 5FU THAT WAS REPORTED TO HAVE COME OUT OF THE BAG, BUT THE PATIENT WAS ABLE TO LUER THE LOCKING INJECTOR BACK ON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912342 BD PHASEAL OPTIMA INJECTOR (N40-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515056 SEE H10 00382905150562

    Patients

    Seq Age Sex Outcome Treatment
    1