BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION ADAPTER C100-O

    MDR report key: 20169504 · Received September 9, 2024

    Report

    Report Number
    3003152976-2024-00499
    Event Type
    Malfunction
    Date Received
    September 9, 2024
    Date of Event
    August 29, 2024
    Report Date
    September 3, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    ONB
    UDI-DI
    00382905150784
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION WITH DEVICE EVALUATION. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. DEVICE EVALUATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING VERIFICATION ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION. AS THE LOT INVOLVED IN THIS INCIDENT IS UNKNOWN, A DEVICE HISTORY REVIEW CANNOT BE PERFORMED, AND ADDITIONAL RETAINED SAMPLES CANNOT BE EVALUATED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    MATERIAL # 515078 BATCH # UNKNOWN IT WAS REPORTED BY CUSTOMER THAT OPTIMA 515078 INFUSION SPIKE CAME LOOSE FROM BAG FILLED WITH ETOPOSIDE CAUSING A SPILL. ADDITIONAL INFORMATION: I DO NOT BELIEVE THIS WAS BD PRODUCT DEFECT. A BRAUN 1000 ML BAG (00264-7800-09) CONTAINING ETOPOSIDE WAS SPIKED USING A BD ALARIS PUMP INFUSION SET (REF (B)(4). THE INFUSION SET CONTAINED A PHASEAL OPTIMA CONNECTOR (C35-O). THE PROCESS WAS COMPLETED IN OUR PHARMACY'S HAZARDOUS DRUG COMPOUNDING HOOD, THERE WAS NO EVIDENCE THE PRODUCT WAS LEAKING AT THAT TIME. THE PRODUCT WAS SENT TO OUR CANCER TREATMENT INFUSION CENTER. THE PRODUCT WAS THEN HUNG ON AN IV POLE. THE NURSE WAS MANIPULATING THE INFUSION SET, WHEN THE SET CAME LOOSE FROM THE IV BAG (SPIKE CAME OUT OF THE PORT), AND THE IV ADMIXTURE LEAKED ON THE FLOOR. TO DIRECTLY ANSWER YOUR QUESTIONS 1) THIS ISSUE OCCURRED WHILE THE PRODUCT WAS IN USE. 2) THERE WAS POSSIBLE EXPOSURE TO A CHEMOTHERAPY TO THE NURSE WHO WAS ASSIGNED TO THE PATIENT. THERE WAS ALSO POTENTIAL OF OTHER NURSE(S) TO BE EXPOSED TO ETOPOSIDE. 3) THERE WAS NO KNOWN HARM, INJURY OR NEGATIVE OUTCOME TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537458 INFUSION ADAPTER C100-O CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB BECTON DICKINSON UNKNOWN 00382905150784

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown