BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ OPTIMA INJECTOR N35-O

    MDR report key: 17446097 · Received August 2, 2023

    Report

    Report Number
    3003152976-2023-00311
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    July 14, 2023
    Report Date
    September 1, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150524
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO PHOTOS OR PHYSICAL SAMPLES WERE PROVIDED FOR EVALUATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2111304, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. RETAINED SAMPLES OF LOT 2111304 WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCTS WERE VISUALLY INSPECTED, NO DAMAGE OR DEFECTS WERE OBSERVED AND ALL CRITICAL DIMENSIONS WERE VERIFIED TO BE WITHIN SPECIFICATION. LEAKAGE AND PRESSURE TESTING IS PERFORMED FOR ALL LOTS DURING MANUFACTURING TO ENSURE THE QUALITY OF THE MEMBRANE. RESULTS WERE REVIEWED FOR THE REPORTED LOT AND VERIFIED TO BE WITHIN SPECIFICATION. BACKPRESSURE TESTING WAS ALSO CONDUCTED ON THE RETURNED SAMPLE, THE RESULTS WERE WITHIN REQUIRED LIMITS, NO LEAKAGE OCCURRED. BASED ON OUR QUALITY TEAM'S INVESTIGATION, THIS INCIDENT LIKELY OCCURRED AS A RESULT OF IMPROPERLY ENGAGING THE DEVICE AS THE INJECTOR MUST BE CONNECTED TO A MATING OPTIMA COMPONENT WHEN ENGAGING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHASEAL¿ OPTIMA INJECTOR N35-O LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CYTARABINE DOSE 1ML DRAWN UP IN LL 1 ML SYRINGE. THE PLUNGER ROD GOT PRESSED AND DRUG LEAKED OUT THE N35-O MEMBRANE. SHE TESTED WITH ALL OTHER SYRINGE SIZES AND THAT WAS THE ONLY ONE THAT DID IT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHASEAL¿ OPTIMA INJECTOR N35-O LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CYTARABINE DOSE <1ML DRAWN UP IN LL 1 ML SYRINGE. THE PLUNGER ROD GOT PRESSED AND DRUG LEAKED OUT THE N35-O MEMBRANE. SHE TESTED WITH ALL OTHER SYRINGE SIZES AND THAT WAS THE ONLY ONE THAT DID IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1466780 BD PHASEAL¿ OPTIMA INJECTOR N35-O INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. UNKNOWN 00382905150524

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown