BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA INFUSION ADAPTER (C100-0 MULTI)

    MDR report key: 10027224 · Received May 5, 2020

    Report

    Report Number
    3003152976-2020-00187
    Event Type
    Malfunction
    Date Received
    May 5, 2020
    Date of Event
    April 14, 2020
    Report Date
    November 18, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150791
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO SAMPLES OR PICTURES WERE RECEIVED FOR THE INVESTIGATION. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1909105. 20 RETAINED SAMPLES FROM C100-O LOT 1909105, 30 SECONDARY IV SETS, 15 BAXTER 500 ML IV BAG AND 15 FK 250 ML IV BAG SODIUM CHLORIDE IV SOLUTION BAGS WERE REQUESTED FOR TESTING FOLLOWING THE TESTING PROCEDURE INCLUDED IN THE PROTOCOL ISSUED. AFTER TESTING, ALL SAMPLES MEET ACCEPTANCE CRITERIA. SINCE NO POTENTIAL MANUFACTURING ISSUES WERE FOUND, RESULTS FROM LOT RELEASE TESTING ON C100-O LOT 1910102 MEET ACCEPTANCE CRITERIA, THE ROOT CAUSE CANNOT BE ESTABLISHED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PHASEAL OPTIMA INFUSION ADAPTERS (C100-0 MULTI) EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WANTED TO LET YOU KNOW THAT WE¿VE HAD AT LEAST 2 INSTANCES IN WHICH THE C100 HAS FALLEN OUT OF THE BAG CAUSING A CHEMO SPILL, MOST RECENTLY TODAY. BOTH INSTANCES INVOLVED OUR REGULAR PVC BAGS (NOT THE PVC FREE, WHICH ALSO HAS HAD THE C100 FALL OUT). NO THE TWO INSTANCES I MENTIONED THE BAGS WERE NOT WERE NOT REFRIGERATED. ONE WAS A FEW WEEKS AGO AND THAT WAS A 500ML NS BAG. TODAY IT HAPPENED ON A NS 250ML BAG (NDC 338-0049-02, LOT Y33271 EXP 8/21). I¿M NOT SURE WHAT LOT/ETC THE C100 WAS FROM AS THE PACKAGING WAS PREVIOUSLY DISPOSED OF IN ANOTHER ROOM. ADDITIONAL INFO: CURRENTLY WE HAVE THE FOLLOWING IN OUR COMPOUNDING ROOM: OPTIMA COMPONENTS C100-O BULK C100 LOT 1910102 EXP 09-30-2020 REFERENCE 515079 THIS COMPLAINT CAPTURES THE EVENT THAT OCCURRED ON 14-APR AND THE OCCURRENCE IN THE PAST ON AN UNKNOWN DATE. ADDITIONAL INFORMATION: BOTH OF MY EXAMPLES OCCURRED WITHIN THE PHARMACY MIXING AREA. IN ONE INSTANCE THE MEDICATION WAS BEING MIXED INSIDE THE HAZARDOUS HOOD. THE TECHNICIAN WAS ADDING CISPLATIN TO THE IV BAG AND THE C100 FELL OUT OF THE BAG AND WE EXPERIENCED A SMALL CHEMOTHERAPY SPILL INSIDE OF THE HOOD. THE SECOND EXAMPLE THE C100 BECAME SEPARATED FROM THE IV BAG WHEN AFTER IT WAS MIXED AND PLACED INSIDE OF A CHEMOTHERAPY TRANSPORT BAG. CHEMOTHERAPY MIXING WAS COMPLETED, FINAL PRODUCT WAS PLACED INTO THE TRANSPORT BAG, AND WHEN THE PHARMACIST WENT TO ADD THE SECOND MEDICATION TO THAT TRANSPORT BAG, THE C100 HAD FALLEN OFF AND CHEMOTHERAPY WAS LEAKING INSIDE OF THE TRANSPORT BAG. I HAVE ALSO HAD THE C100 FALL OUT OF OUR PVC FREE BAGS WHEN I WAS PUTTING THE FINAL PRODUCT INTO THE TRANSPORT BAG.

    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 2 BD PHASEAL OPTIMA INFUSION ADAPTERS (C100-0 MULTI) EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WANTED TO LET YOU KNOW THAT WE¿VE HAD AT LEAST 2 INSTANCES IN WHICH THE C100 HAS FALLEN OUT OF THE BAG CAUSING A CHEMO SPILL, MOST RECENTLY TODAY. BOTH INSTANCES INVOLVED OUR REGULAR PVC BAGS (NOT THE PVC FREE, WHICH ALSO HAS HAD THE C100 FALL OUT). NO THE TWO INSTANCES I MENTIONED THE BAGS WERE NOT WERE NOT REFRIGERATED. ONE WAS A FEW WEEKS AGO AND THAT WAS A 500 ML NS BAG. TODAY IT HAPPENED ON A NS 250 ML BAG (NDC 338-0049-02, LOT Y33271 EXP 8/21). I¿M NOT SURE WHAT LOT/ETC THE C100 WAS FROM AS THE PACKAGING WAS PREVIOUSLY DISPOSED OF IN ANOTHER ROOM. ADDITIONAL INFO: CURRENTLY WE HAVE THE FOLLOWING IN OUR COMPOUNDING ROOM: OPTIMA COMPONENTS C100-O BULK C100, LOT 1910102, EXP 09-30-2020, REFERENCE 515079. THIS COMPLAINT CAPTURES THE EVENT THAT OCCURRED ON 14-APR AND THE OCCURRENCE IN THE PAST ON AN UNKNOWN DATE. ADDITIONAL INFORMATION: BOTH OF MY EXAMPLES OCCURRED WITHIN THE PHARMACY MIXING AREA. IN ONE INSTANCE THE MEDICATION WAS BEING MIXED INSIDE THE HAZARDOUS HOOD. THE TECHNICIAN WAS ADDING CISPLATIN TO THE IV BAG AND THE C100 FELL OUT OF THE BAG AND WE EXPERIENCED A SMALL CHEMOTHERAPY SPILL INSIDE OF THE HOOD. THE SECOND EXAMPLE THE C100 BECAME SEPARATED FROM THE IV BAG WHEN AFTER IT WAS MIXED AND PLACED INSIDE OF A CHEMOTHERAPY TRANSPORT BAG. CHEMOTHERAPY MIXING WAS COMPLETED, FINAL PRODUCT WAS PLACED INTO THE TRANSPORT BAG, AND WHEN THE PHARMACIST WENT TO ADD THE SECOND MEDICATION TO THAT TRANSPORT BAG, THE C100 HAD FALLEN OFF AND CHEMOTHERAPY WAS LEAKING INSIDE OF THE TRANSPORT BAG. I HAVE ALSO HAD THE C100 FALL OUT OF OUR PVC FREE BAGS WHEN I WAS PUTTING THE FINAL PRODUCT INTO THE TRANSPORT BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486964 BD PHASEAL OPTIMA INFUSION ADAPTER (C100-0 MULTI) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1910102 00382905150791

    Patients

    Seq Age Sex Outcome Treatment
    1 Other