BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA INJECTOR (N40-O)

    MDR report key: 12501090 · Received September 20, 2021

    Report

    Report Number
    3003152976-2021-00609
    Event Type
    Malfunction
    Date Received
    September 20, 2021
    Date of Event
    July 15, 2021
    Report Date
    October 12, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150562
    PMA / PMN Number
    K201099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW, IT WAS FOUND THAT THIS EVENT WAS ALREADY CAPTURED UNDER MFR REPORT # 3003152976-2021-00589. THIS EVENT HAS BEEN OVER-REPORTED AND WILL BE CANCELLED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA INJECTOR (N40-O) IV TUBING DISCONNECTED FROM THE PATIENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENTS CALL BELL WAS GOING OFF, WENT INTO ROOM, IV TUBING WAS ON FLOOR, MOTHER STATED HER TUBING JUST FELL OFF FROM THE PATIENT. TUBING DISCONNECTED WHERE TUBING CONNECTED TO PATIENT."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. FDA NOTIFIED?: THE INITIAL REPORTER ALSO NOTIFIED THE FDA VIA MEDWATCH # MW5103056. 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 BD PHASEAL¿ OPTIMA INJECTOR (N40-O) IV TUBING DISCONNECTED FROM THE PATIENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENTS CALL BELL WAS GOING OFF, WENT INTO ROOM, IV TUBING WAS ON FLOOR, MOTHER STATED HER TUBING JUST FELL OFF FROM THE PATIENT. TUBING DISCONNECTED WHERE TUBING CONNECTED TO PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1394561 BD PHASEAL OPTIMA INJECTOR (N40-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515056 UNKNOWN 00382905150562

    Patients

    Seq Age Sex Outcome Treatment
    1