BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA INJECTOR (N35-O)

    MDR report key: 12147805 · Received July 9, 2021

    Report

    Report Number
    3003152976-2021-00385
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Date of Event
    May 3, 2021
    Report Date
    August 13, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 2012309, 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. FIVE RETAINED SAMPLES FROM LOT 2012309 WERE USED FOR ADDITIONAL EVALUATION, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL OPTIMA INJECTOR (N35-O) EXPERIENCED LEAKAGE FROM THE INJECTOR AND MATING COMPONENT, AND SEPARATION OF INJECTOR AND MATING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE WAS CALLED INTO THE PATIENT'S ROOM. THE PATIENT HAD 2 DROPS OF BLOOD ON HER LEGS, AND HER BED HAD BLOOD ON IT. THE PHASEAL OPTIMA INJECTOR, CONNECTOR, AND BLUE COVER WERE ALL STILL INTACT AND CONNECTED TO THE PATIENT'S PORT. HOWEVER, THE IV TUBING ATTACHED TO THE 24 HR MTX CAME WAS UNSCREWED AND HANGING OFF THE BED. THE NURSE QUICKLY TURNED OFF THE IV PUMP AND FURTHER ASSESSED THE SITUATION. DAD HELD THE PATIENT WITH DOUBLE GLOVES AND WIPED HER OFF USING BATH WIPES. THE NURSE SAW THAT THE OPTIMA AND PORT WERE LEAKING BLOOD SO SHE CLAMPED THAT UNTIL SHE COULD DISCONNECT THE OPTIMA AND FLUSH THE PORT. THE PORT WAS STILL IN PLACE WITH THE DRESSING INTACT, LINE WAS FLUSHED, BLOOD RETURN NOTED AND SALINE LOCKED. PCT CHANGED LINENS USING DOUBLE GLOVES AND WIPED THE BED USING PURPLE SANIWIPES. THERE WAS NO CHEMO SPILL ANYWHERE ELSE, ONLY THE DROPS OF BLOOD. THE NURSE NOTIFIED THE CHARGE NURSE, RESIDENT, HOSPITALIST, PHARMACY AND ATTENDING. THE ATTENDING DID NOT WANT TO RESTART THE CHEMO, SO THE NURSE PRIMED A NEW IV TUBING WITH IVF AND CHANGED THE CAP ON THE PORT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PHASEAL OPTIMA INJECTOR (N35-O) EXPERIENCED LEAKAGE FROM THE INJECTOR AND MATING COMPONENT, AND SEPARATION OF INJECTOR AND MATING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE WAS CALLED INTO THE PATIENT'S ROOM. THE PATIENT HAD 2 DROPS OF BLOOD ON HER LEGS, AND HER BED HAD BLOOD ON IT. THE PHASEAL OPTIMA INJECTOR, CONNECTOR, AND BLUE COVER WERE ALL STILL INTACT AND CONNECTED TO THE PATIENT'S PORT. HOWEVER, THE IV TUBING ATTACHED TO THE 24 HR MTX CAME WAS UNSCREWED AND HANGING OFF THE BED. THE NURSE QUICKLY TURNED OFF THE IV PUMP AND FURTHER ASSESSED THE SITUATION. DAD HELD THE PATIENT WITH DOUBLE GLOVES AND WIPED HER OFF USING BATH WIPES. THE NURSE SAW THAT THE OPTIMA AND PORT WERE LEAKING BLOOD SO SHE CLAMPED THAT UNTIL SHE COULD DISCONNECT THE OPTIMA AND FLUSH THE PORT. THE PORT WAS STILL IN PLACE WITH THE DRESSING INTACT, LINE WAS FLUSHED, BLOOD RETURN NOTED AND SALINE LOCKED. PCT CHANGED LINENS USING DOUBLE GLOVES AND WIPED THE BED USING PURPLE SANIWIPES. THERE WAS NO CHEMO SPILL ANYWHERE ELSE, ONLY THE DROPS OF BLOOD. THE NURSE NOTIFIED THE CHARGE NURSE, RESIDENT, HOSPITALIST, PHARMACY AND ATTENDING. THE ATTENDING DID NOT WANT TO RESTART THE CHEMO, SO THE NURSE PRIMED A NEW IV TUBING WITH IVF AND CHANGED THE CAP ON THE PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039335 BD PHASEAL OPTIMA INJECTOR (N35-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2012309

    Patients

    Seq Age Sex Outcome Treatment
    1