BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA INJECTOR (N35-O)

    MDR report key: 10047831 · Received May 12, 2020

    Report

    Report Number
    3003152976-2020-00199
    Event Type
    Malfunction
    Date Received
    May 12, 2020
    Date of Event
    April 17, 2020
    Report Date
    May 27, 2020
    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 SUSPECTED LOTS 1910109 AND 1909103 , 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. THREE RETAINED INJECTOR SAMPLES FROM LOT 1910109 AND THREE FROM LOT 1909103 WERE INSPECTED, NO DAMAGE WAS OBSERVED ON THE PRODUCT AND ALL LUER DIMENSIONS WERE VERIFIED TO BE WITHIN THE REQUIRED SPECIFICATIONS. FUNCTIONAL TESTING WAS PERFORMED, CONNECTING ONE INJECTOR FORM EACH LOT TO A SAMPLE SYRINGE, PROTECTOR AND VIAL ACCORDING TO THE INSTRUCTIONS FOR USE. EACH SAMPLE WAS TESTED THREE TIMES AND IN ALL CASES THE PRODUCT FUNCTIONED PROPERLY, AND NO ISSUES WERE OBSERVED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE INJECTOR OR OUR MANUFACTURING PROCESS AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INJECTOR N35-O EXPERIENCED A BROKEN LUER CONNECTION THAT LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515052, BATCH NO: UNKNOWN. THERE ARE MANY COMPLAINTS FROM NURSING. I HAVE NO OTHER INFORMATION THAN WHAT IS PROVIDED AND WOULD WANT YOU TO ONLY CONTACT ME WITH ADDITIONAL QUESTIONS AND THE CLOSURE LETTER PLEASE. EVENT DESCRIPTION: SI 96152 4/17 THE WHITE CONNECTOR (OPTIMA INJECTOR) OF THE TACRO TUBING GOT DISCONNECTED FROM THE LOWEST PORT OF THE MAIN TACRO LINE. HANG TIME: (B)(6) 2020 AT 1303. DISCONNECTION TIME: (B)(6) 2020 AT 1430.

    Additional Manufacturer Narrative · 1

    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 INJECTOR N35-O EXPERIENCED A BROKEN LUER CONNECTION THAT LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515052, BATCH NO: UNKNOWN. THERE ARE MANY COMPLAINTS FROM NURSING. I HAVE NO OTHER INFORMATION THAN WHAT IS PROVIDED AND WOULD WANT YOU TO ONLY CONTACT ME WITH ADDITIONAL QUESTIONS AND THE CLOSURE LETTER PLEASE. EVENT DESCRIPTION: SI 96152 (B)(6) THE WHITE CONNECTOR (OPTIMA INJECTOR) OF THE TACRO TUBING GOT DISCONNECTED FROM THE LOWEST PORT OF THE MAIN TACRO LINE. HANG TIME: (B)(6) 2020 AT 1303, DISCONNECTION TIME: (B)(6) 2020 AT 1430.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509918 BD PHASEAL OPTIMA INJECTOR (N35-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other