BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION ADAPTER C100-O

    MDR report key: 9446320 · Received December 10, 2019

    Report

    Report Number
    3003152976-2019-00847
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    November 22, 2019
    Report Date
    February 18, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    K181221
    Adverse Event
    Yes
    Product Problem
    Yes
    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 LOT 1902101, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. DURING MANUFACTURING, LEAKAGE TESTING IS PERFORMED, PENETRATING THE INJECTOR TEN TIMES TO VERIFY IF ANY LEAKS OCCUR. TESTING WAS REVIEWED FOR INJECTOR LOT 1902101 , ALL RESULTS WERE FOUND TO BE WITHIN SPECIFICATION. FIVE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. FUNCTIONAL TESTING WAS PERFORMED, PENETRATING THE ADAPTER ALONG WITH A SAMPLE INJECTOR TEN TIMES, ALL RESULTS WERE FOUND TO BE ACCEPTABLE WITH NO LEAKS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    MATERIAL NO: 515078, BATCH NO: 1902101. IT WAS REPORTED THAT DURING USE OF THE INFUSION ADAPTER C100-O THERE WAS AN ISSUE WITH LEAKAGE. THE CLINICIAN VISUALIZED A DROP OF FLUID DURING DISCONNECT ON INFUSION ADAPTER WHEN UNDER HOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLINICIAN VISUALIZED A DROP OF FLUID DURING DISCONNECT ON INFUSION ADAPTER WHEN UNDER HOOD.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO: 515078, BATCH NO: 1902101. IT WAS REPORTED THAT DURING USE OF THE INFUSION ADAPTER C100-O THERE WAS AN ISSUE WITH LEAKAGE. THE CLINICIAN VISUALIZED A DROP OF FLUID DURING DISCONNECT ON INFUSION ADAPTER WHEN UNDER HOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLINICIAN VISUALIZED A DROP OF FLUID DURING DISCONNECT ON INFUSION ADAPTER WHEN UNDER HOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243350 INFUSION ADAPTER C100-O INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1902101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other