BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INFUSION ADAPTER C100

    MDR report key: 17786032 · Received September 20, 2023

    Report

    Report Number
    3003152976-2023-00403
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    August 23, 2023
    Report Date
    November 22, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905153068
    PMA / PMN Number
    K123213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2201217, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THREE RETAINED SAMPLES OF THE REPORTED LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, THERE WAS NO DAMAGE OR OTHER DEFECTS OBSERVED ON ANY OF THE INFUSION ADAPTERS. FUNCTIONAL TESTING WAS PERFORMED, CONNECTING THE ADAPTER TO AN INFUSION BAG, ALONG WITH AN INJECTOR AND SYRINGE. LIQUID WAS EXTRACTED FROM THE INFUSION BAG AND REINTRODUCED INTO THE BAG, FLUID MOVED THROUGH THE SYSTEM WITHOUT ISSUE AND NO LEAKAGE WAS OBSERVED. LEAKAGE TESTING WAS PERFORMED, PENETRATING THE MEMBRANE UP TO TEN TIMES. IN ALL CASES THE PRODUCT FUNCTIONED AS INTENDED AND NO LEAKAGE THROUGH THE MEMBRANE OR ANY COMPONENTS OCCURRED. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, NO ISSUES WERE FOUND DURING THESE INSPECTIONS. BASED ON THE AVAILABLE INFORMATION, WE CANNOT IDENTIFY A ROOT CAUSE RELATED TO OUR PRODUCT OR MANUFACTURING PROCESS AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. H3 OTHER TEXT : SEE MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. 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 · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ INFUSION ADAPTER C100 EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON RECEIVING ADRIAMYCIN IVPB IN CHEMO BAG, AS I WAS SCANNING THE BARCODE I NOTICED A SMALL DROPLET ON THE OUTSIDE TUBING NEAREST THE INSERTION SITE ON THE BAG. VERBATIM: BD PHASEAL INFUSION ADAPTER C100 REF 515306, LOT 2201217 MANUFACTURE DATE 2022-01-01 EXP 2025-12-31.UPON RECEIVING ADRIAMYCIN IVPB IN CHEMO BAG, AS I WAS SCANNING THE BARCODE I NOTICED A SMALL DROPLET ON THE OUTSIDE TUBING NEAREST THE INSERTION SITE ON THE BAG, I INSPECTED THE REST OF THE TUBING AND BAG OF ADRIAMYCIN AND FOUND NO MORE DROPS. THE LINE HAD BEEN PRIMED WITH SALINE PER FACILITY PROTOCOL. IT IS SUSPECTED THAT THERE WAS A MEMBRANE DISFUNCTION AT THE PHASEAL CONNECTOR PORT. PLEASE LET ME KNOW IF YOU HAVE ANY QUESTIONS. RESPONSE RECEIVED ON 18-SEP-2023: 1. ARE YOU ABLE TO CONFIRM IF THERE WAS ANY PATIENT INVOLVEMENT? IF YES, WHAT WAS THE PATIENT OUTCOME? - 1. NO PT INVOLVEMENT. 2. WAS THERE ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED? - 2. NO ADVERSE EVENT OR SERIOUS INJURY. 3. PLEASE CONFIRM THE DATE OF INCIDENT. - 3. 8/23/23. 4. ARE YOU ABLE TO PROVIDE THE QUANTITY OF DEFECTIVE PRODUCT INSPECTED? - 4. JUST 1 DEFECTIVE THAT WE¿VE NOTICED. 5. WHAT TYPE OF PROCEDURE WAS BEING PERFORMED DURING THE INCIDENT? - 5. DOXORUBICIN INFUSION. 6. WHAT MEDICATION/SOLUTION WAS USED? -6. DOXORUBICIN. 7. WAS THE PROCEDURE COMPLETED AS PLANNED? -7. YES. 8. IS SAMPLE AVAILABLE TO BE RETURN? IF NO, CAN A PHOTO BE PROVIDED? -8. NO, NO. 9. WAS THE LEAK BETWEEN THE CONNECTION OF THE SPIKE AND INFUSION BAG OR WAS IT NEAR THE SPIKE PORT, CLOSER TO THE TUBING CONNECTION? - 9. THE LEAK WAS FROM THE ACCESS PORT IN THE BD INFUSION ADAPTER (C100) DUE TO A DEFECTIVE CSTD MEMBRANE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ INFUSION ADAPTER C100 EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON RECEIVING ADRIAMYCIN IVPB IN CHEMO BAG, AS I WAS SCANNING THE BARCODE I NOTICED A SMALL DROPLET ON THE OUTSIDE TUBING NEAREST THE INSERTION SITE ON THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519422 BD PHASEAL¿ INFUSION ADAPTER C100 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2201217 00382905153068

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown