BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3003152976-2019-00852

    MDR report key: 9459689 · Received December 12, 2019

    Report

    Report Number
    3003152976-2019-00852
    Event Type
    Malfunction
    Date Received
    December 12, 2019
    Report Date
    February 3, 2020
    Product Code
    ONB
    PMA / PMN Number
    K181221
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 REPORTED LOT 1907105, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FOUR RETAINED SAMPLES OF LOT 1907105 WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED WITH NO DEFECTS OBSERVED. TESTING WAS PERFORMED, ENGAGING AND DISENGAGING THE PRODUCT AND ALL SAMPLES FUNCTIONED AS INTENDED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONNECTOR SEPARATED FROM THE INJECTOR DURING USE WITH A BD PHASEAL INJECTOR N35-O. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS). IT WAS REPORTED THAT THE CONNECTOR SEPARATED FROM THE INJECTOR. DRY DISCONNECTS FROM PATIENTS RECEIVING CHEMOTHERAPY ON IN-PATIENT ONCOLOGY UNITS AT HUP. ONE PATIENT DISCONNECTED LESS THAN 4 HOURS AFTER INFUSION BEGAN. ALL DISCONNECTS OCCURRED AT THE PATIENT SITE ACCESS, AS THIS IS WHERE CHEMO IS CONNECTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO HAVE POSSIBLY BEEN INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1907105. MEDICAL DEVICE EXPIRATION DATE: 2020-02-29. DEVICE MANUFACTURE DATE: 2019-07-19. MEDICAL DEVICE LOT #: UNKNOWN, 1902101 WAS REPORTED, HOWEVER, THAT IS NOT A LOT FOR THIS PRODUCT. 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 THE CONNECTOR SEPARATED FROM THE INJECTOR DURING USE WITH A BD PHASEAL INJECTOR N35-O. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS) IT WAS REPORTED THAT THE CONNECTOR SEPARATED FROM THE INJECTOR. DRY DISCONNECTS FROM PATIENTS RECEIVING CHEMOTHERAPY ON IN-PATIENT ONCOLOGY UNITS AT HUP. ONE PATIENT DISCONNECTED LESS THAN 4 HOURS AFTER INFUSION BEGAN. ALL DISCONNECTS OCCURRED AT THE PATIENT SITE ACCESS, AS THIS IS WHERE CHEMO IS CONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257909 ONB
    1257910 ---

    Patients

    Seq Age Sex Outcome Treatment
    1 Other