BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA INJECTOR (N35-O)

    MDR report key: 12651950 · Received October 18, 2021

    Report

    Report Number
    3003152976-2021-00695
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Date of Event
    September 20, 2021
    Report Date
    December 3, 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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 10/26/2021. H.6. INVESTIGATION: TWO OPTIMA INJECTORS (N35-0) , ONE FROM LOT 2011320 AND ANOTHER ONE FROM LOT 2102316 WERE RECEIVED FOR THE INVESTIGATION OF THE EVENT REPORTED. AFTER A VISUAL INSPECTION OF BOTH SAMPLES RECEIVED NO ANOMALIES OR DAMAGES WERE FOUND ON THE SAMPLES THAT COULD BE RELATED TO THE EVENT REPORTED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOTS 2011320, 2102316 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES A SERIES OF INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING FLOW RATE VERIFICATION. FUNCTIONAL TESTING WAS PERFORMED, PENETRATING THE INJECTOR ALONG WITH A SAMPLE SYRINGE AND MATING COMPONENTS TEN TIMES, ALL RESULTS WERE FOUND TO BE ACCEPTABLE WITH NO LEAKS IDENTIFIED. BASED ON THE QUALITY TEAM'S INVESTIGATION, 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 3 BD PHASEAL OPTIMA INJECTORS (N35-O) EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSERVICE CONSULTANT ONSITE PROVIDING POST-CONVERSION INSERVICING SUPPORT WITH BD PHASEAL OPTIMA. REPORTS OF LEAKING INJECTOR X 3 WHEN ADMINISTERING SUBCUTANEOUS MEDICATION. SPECIFICALLY WHEN CONNECTING THE INJECTOR/SYRINGE UNIT TO THE CONNECTOR/NEEDLE UNIT PRIOR TO SC INJECTION. OCCURRENCES WITH 3 AND 5 ML SYRINGES. STAFF INDICATED THAT OCCURRED 'EARLY SUMMER' WITH 3 DIFFERENT NURSES. LOT NUMBERS AND SAMPLE OF 2 LOTS IDENTIFIED AVAILABLE FOR REVIEW. BD WAS NOT NOTIFIED AT THE TIME. THE 3 NURSES INDICATED THAT IT ONLY OCCURRED ONCE FOR EACH OF THEM. THE MEDICATION BEING ADMINISTERED WAS VELCADE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE #:(B)(6). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2011320. MEDICAL DEVICE EXPIRATION DATE: 2022-01-31. DEVICE MANUFACTURE DATE: 2020-12-09. MEDICAL DEVICE LOT #: 2102316. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30. DEVICE MANUFACTURE DATE: 2021-02-24. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 3 BD PHASEAL OPTIMA INJECTORS (N35-O) EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSERVICE CONSULTANT ONSITE PROVIDING POST-CONVERSION INSERVICING SUPPORT WITH BD PHASEAL OPTIMA. REPORTS OF LEAKING INJECTOR X 3 WHEN ADMINISTERING SUBCUTANEOUS MEDICATION. SPECIFICALLY WHEN CONNECTING THE INJECTOR/SYRINGE UNIT TO THE CONNECTOR/NEEDLE UNIT PRIOR TO SC INJECTION. OCCURRENCES WITH 3 AND 5 ML SYRINGES. STAFF INDICATED THAT OCCURRED 'EARLY SUMMER' WITH 3 DIFFERENT NURSES. LOT NUMBERS AND SAMPLE OF 2 LOTS IDENTIFIED AVAILABLE FOR REVIEW. BD WAS NOT NOTIFIED AT THE TIME. THE 3 NURSES INDICATED THAT IT ONLY OCCURRED ONCE FOR EACH OF THEM. THE MEDICATION BEING ADMINISTERED WAS VELCADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1547168 BD PHASEAL OPTIMA INJECTOR (N35-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. UNKNOWN 00382905150524

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown