BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ OPTIMA INJECTOR N35-O

    MDR report key: 12639857 · Received October 15, 2021

    Report

    Report Number
    3003152976-2021-00691
    Event Type
    Malfunction
    Date Received
    October 15, 2021
    Date of Event
    September 17, 2021
    Report Date
    November 19, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150524
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: D.3. MEDICAL DEVICE MANUFACTURER: SAN AGUSTIN.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES OR PHOTOS RECEIVED FOR INVESTIGATION. NINE RETAINED SAMPLES FROM EACH LOT WERE EVALUATED, AND LUER LOCK MEASURED, NO DAMAGE OR DEFECTS OBSERVED, MEASUREMENTS MET ACCEPTANCE CRITERIA. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2103305, 2011503 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 TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING VERIFICATION ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION AND THERE IS NO DAMAGE ON THE PRODUCT. TESTING RESULTS WERE REVIEWED FOR THE REPORTED LOT AND FOUND ALL PRODUCT MET REQUIRED SPECIFICATIONS. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. IT SHOULD BE CONSIDERED THAT INJECTOR/CONNECTOR SEPARATION FAILURE MODE IS A DRY DISCONNECT WHICH PREVENTS LEAKAGE BY DESIGN. IT IS RECOMMENDED TO USE THE OPTIONAL M25-O CLAMP TO AVOID DRY DISCONNECTS DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PHASEAL¿ OPTIMA INJECTOR N35-O SEPARATED FROM THE CONNECTOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE BD BD PHASEAL IS COMING LOOSE AT THE CONNECTIONS. IT WAS VERY LOOSE AND CAME APART ON IT'S OWN. CUSTOMER IS REQUESTING MORE PRODUCT KNOWLEDGE AND WONDERING WHAT ELSE IS ABLE TO CONNECT TO THIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PHASEAL¿ OPTIMA INJECTOR N35-O SEPARATED FROM THE CONNECTOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE BD BD PHASEAL IS COMING LOOSE AT THE CONNECTIONS. IT WAS VERY LOOSE AND CAME APART ON IT'S OWN. CUSTOMER IS REQUESTING MORE PRODUCT KNOWLEDGE AND WONDERING WHAT ELSE IS ABLE TO CONNECT TO THIS.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6), USA HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PHASEAL¿ OPTIMA INJECTOR N35-O SEPARATED FROM THE CONNECTOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE BD BD PHASEAL IS COMING LOOSE AT THE CONNECTIONS. IT WAS VERY LOOSE AND CAME APART ON IT'S OWN. CUSTOMER IS REQUESTING MORE PRODUCT KNOWLEDGE AND WONDERING WHAT ELSE IS ABLE TO CONNECT TO THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536893 BD PHASEAL¿ OPTIMA INJECTOR N35-O INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2103305 00382905150524

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CONNECTOR C35-O