BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INFUSION ADAPTER C100

    MDR report key: 16714625 · Received April 11, 2023

    Report

    Report Number
    3003152976-2023-00129
    Event Type
    Malfunction
    Date Received
    April 11, 2023
    Date of Event
    March 21, 2023
    Report Date
    May 12, 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
    AS
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMAR. PHOTO RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, INFUSION ADAPTER LEAKING BY THE ADAPTER PORT IS OBSERVED. THE INFUSION ADAPTERS HAVE A SEPTUM INSIDE THE ADAPTER PORT WHICH PROVIDES A SEAL, THAT ONCE SPIKED, CANNOT BE UN-SPIKED AS A LEAKAGE CAN OCCUR. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2203218, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED ISSUE. THREE RETAINED SAMPLES FROM THE SAME LOT WERE EVALUATED. THE PRODUCT WAS VISUALLY INSPECTED, THERE WAS NO DAMAGE OR DEFECTS IDENTIFIED ON THE INFUSION ADAPTERS OR SEPTUM'S OF THE ADAPTER PORT. PRODUCT UNDERGOES A SERIES OF TESTING AND INSPECTIONS DURING MANUFACTURING TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING LEAKAGE TESTING. ALL RECORDS WERE REVIEWED FOR THE REPORTED LOT AND RESULTS WERE FOUND TO BE ACCEPTABLE, PRODUCT MET REQUIRED SPECIFICATIONS. LEAKAGE TESTING WAS ALSO PERFORMED ON THE RETAINED SAMPLES AND NO LEAKAGES OCCURRED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME, IT APPEARS AS THOUGH THE ADAPTER PORT MAY HAVE PREVIOUSLY BEEN SPIKED, RESULTING IN THE LEAK OBSERVED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ INFUSION ADAPTER C100 LEAKED WHEN USED WITH THE LIPOSOMAL DOXORUBICIN BAG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACIST. REPORTED 1 LIPOSOMAL DOXORUBICIN BAG HAD A LEAK IN THE ONCOLOGY DAY UNIT WHEN THEY OPENED THE BAG. THE LEAK IS ORIGINATING FROM THE ANCILLARY ITEM PROVIDED WITH THE PRODUCT; PHASEAL ADAPTOR. FURTHER INFORMATION REQUESTED FROM CUSTOMER. INCLUDING WHETHER ANY LEAK WAS OBSERVED PRIOR TO REMOVING PRODUCT FROM OVERPOUCH, AT WHICH STAGE EXACTLY THE LEAK WAS IDENTIFIED, WHETHER THERE WAS ANY SKIN CONTACT WITH ANY SPILLED CYTOTOXIC SOLUTION AND IF SKIN CONTACT OCCURRED, WHAT ACTIONS WERE TAKEN IMMEDIATELY AFTER ANY SPILL SKIN CONTACT, WHETHER THERE WAS ANY REPORT OF STAFF / PATIENT INJURY, OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT, AND WHETHER THERE WAS ANY DAMAGE OBSERVED TO THE PHASEAL ADAPTOR, THE PRODUCT PACKAGING, OR THE CARTON THE PRODUCT WAS RECEIVED IN. THIS WAS IDENTIFIED AT THE HOSPITAL ON (B)(6) 2023."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ INFUSION ADAPTER C100 LEAKED WHEN USED WITH THE LIPOSOMAL DOXORUBICIN BAG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACIST... REPORTED 1 LIPOSOMAL DOXORUBICIN BAG HAD A LEAK IN THE ONCOLOGY DAY UNIT WHEN THEY OPENED THE BAG... THE LEAK IS ORIGINATING FROM THE ANCILLARY ITEM PROVIDED WITH THE PRODUCT; PHASEAL ADAPTOR... FURTHER INFORMATION REQUESTED FROM CUSTOMER... INCLUDING WHETHER ANY LEAK WAS OBSERVED PRIOR TO REMOVING PRODUCT FROM OVERPOUCH, AT WHICH STAGE EXACTLY THE LEAK WAS IDENTIFIED, WHETHER THERE WAS ANY SKIN CONTACT WITH ANY SPILLED CYTOTOXIC SOLUTION AND IF SKIN CONTACT OCCURRED, WHAT ACTIONS WERE TAKEN IMMEDIATELY AFTER ANY SPILL SKIN CONTACT, WHETHER THERE WAS ANY REPORT OF STAFF / PATIENT INJURY, OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT, AND WHETHER THERE WAS ANY DAMAGE OBSERVED TO THE PHASEAL ADAPTOR, THE PRODUCT PACKAGING, OR THE CARTON THE PRODUCT WAS RECEIVED IN. THIS WAS IDENTIFIED AT THE HOSPITAL ON (B)(6) 2023."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1624187 BD PHASEAL¿ INFUSION ADAPTER C100 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515306 2203218 00382905153068

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown