BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SECONDARY SET C61

    MDR report key: 21048098 · Received December 31, 2024

    Report

    Report Number
    2243072-2024-01272
    Event Type
    Malfunction
    Date Received
    December 31, 2024
    Date of Event
    December 6, 2024
    Report Date
    January 17, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    ONB
    UDI-DI
    00382905153020
    PMA / PMN Number
    K123213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT 515302, LOT 1030249, QTY (B)(4) PCS, WAS PRODUCED IN SEP 2024. MANUFACTURING PROCESS WAS CONDUCTED IN ACCORDANCE WITH DOCUMENT 15-0137 AND ALL QUALITY CONTROL ACTIVITIES HAVE BEEN PERFORMED ACCORDING TO QUALITY SPECIFICATION 10-0160 AND 10-0255. ACCORDING TO DHR, THERE WERE NO QUALITY NOTIFICATIONS OBSERVED DURING MANUFACTURING PROCESS RELATED TO CUSTOMER COMPLAINT. SAMPLE HAS NOT BEEN RECEIVED. BASED ON THE PICTURE AND VIDEO PROVIDED FROM THE CUSTOMER, IT CAN BE CONFIRMED CUSTOMER EXPERIENCE. THIS DEFECT IS CLASSIFIED AS C4.2 - LEAKAGE, WHICH CAUSES RISK FOR PATIENT AND/OR USER. RETAIN SAMPLE HAVE BEEN EXAMINED, AND IT CAN BE CONFIRMED THAT ALL COMPONENTS ARE PRESENT. THERE IS NO DEFECT OBSERVED DURING THIS EXAMINATION. DURING ASSEMBLY, THE PRODUCT UNDERGOES A 100% LEAK INSPECTION, AND THIS IS DEFINED IN PROCEDURE (B)(4). IF THE LEAKING PRODUCT IS DETECTED IN THE 100% TESTING PROCESS, IT WILL BE SEPARATED AS SCRAP. DURING THE INSPECTION OF RETAINED SAMPLE IT WAS ESTABLISHED THAT THE SYSTEM DOES NOT LEAK. THE EXACT DEFECT CANNOT BE DETERMINED BASED ON THE IMAGE OR VIDEO. IT CANNOT BE SEEN WHETHER THERE IS A LEAK AT THE CONNECTION OF THE HOSE AND THE SPIKE, WHETHER THE SPIKE IS DAMAGED, OR SOME OTHER DEFECT CAUSED THE LEAK.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    CAN YOU CONFIRM THE APPROXIMATE LOCATION OF THE LEAKAGE ON THE ADAPTER? -THE LEAKAGE WAS OBSERVED AT THE JUNCTION BETWEEN THE TRANSPARENT TUBING AND THE BODY OF THE ADAPTER, WHERE A WHITE ERGO CAN BE SEEN TO WHICH THE TUBING IS ATTACHED. CAN YOU CONFIRM THAT THE ADAPTER HAS SUFFERED ANY OBVIOUS DAMAGE? -THERE'S NO OBVIOUS DAMAGE TO THE ADAPTER! CAN YOU CONFIRM THAT YOU ARE ABLE TO PROVIDE OUR TEAM WITH AN IMAGE OR VIDEO OF THE LEAKAGE AS IT OCCURS? -WE'LL TRY TO SEND THIS TO YOU, BUT THERE'S NO GUARANTEE OF RESULTS! CAN YOU CONFIRM THAT THE SAME ADAPTER WAS USED FOR BOTH PREPARED BAGS? -YES, WE'VE USED THE SAME ADAPTERS ON OTHER PREPARATIONS WITHOUT NOTICING ANY LEAKAGE; FORTUNATELY! **NO ADDITIONAL INFORMATION RECEIVED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SECONDARY SET C61 LEAKED DURING THE CHEMOTHERAPY CHECK BY THE PHARMACIST, A LEAK OF CHEMO (DOXORUBICIN) LEAKED FROM THE INFUSION BAG ADAPTER (THE PATIENT'S BAG HAD TO BE RE-PREPARED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820859 BD SECONDARY SET C61 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON 1030249 00382905153020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown