BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION ADAPTER C100

    MDR report key: 9869143 · Received March 23, 2020

    Report

    Report Number
    3002682307-2020-00108
    Event Type
    Malfunction
    Date Received
    March 23, 2020
    Date of Event
    February 26, 2020
    Report Date
    April 14, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905153068
    PMA / PMN Number
    K123213
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO UNUSED SAMPLES WERE RETURNED TO OUR QUALITY ENGINEER FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS WERE OBSERVED ON THE ADAPTER SPIKE, MEMBRANE, OR OTHER COMPONENTS. LEAKAGE TESTING WAS PERFORMED AND IN ALL CASES THE PRODUCT FUNCTIONED AS INTENDED AND NO LEAKS WERE OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1905106, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED ISSUE. PRODUCT UNDERGOES A SERIES OF TESTING AND INSPECTIONS DURING MANUFACTURING TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. ALL RECORDS WERE REVIEWED FOR THE REPORTED LOT AND RESULTS WERE FOUND TO BE ACCEPTABLE, PRODUCT MET REQUIRED SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF INFUSION ADAPTERS C100 EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THE MEDICAL ONCOLOGY DEPARTMENT THE PATIENT RECEIVED OXALIPLATIN TREATMENT, THE TREATMENT AREA WAS SCATTERED ON THE PUMP AND 15 ML OF THE DRUG FROM THE C100 ADAPTER, WHICH WAS ATTACHED TO THE SET. SPILLED MEDICATION CLEANED AND ROOM VENTILATED.

    Additional Manufacturer Narrative · 1

    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 AN UNSPECIFIED NUMBER OF INFUSION ADAPTERS C100 EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THE MEDICAL ONCOLOGY DEPARTMENT THE PATIENT RECEIVED OXALIPLATIN TREATMENT, THE TREATMENT AREA WAS SCATTERED ON THE PUMP AND 15 ML OF THE DRUG FROM THE C100 ADAPTER, WHICH WAS ATTACHED TO THE SET. SPILLED MEDICATION CLEANED AND ROOM VENTILATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334077 INFUSION ADAPTER C100 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515306 1905106 00382905153068

    Patients

    Seq Age Sex Outcome Treatment
    1 Other