BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ OPTIMA PROTECTOR (P20-O)

    MDR report key: 9273380 · Received November 4, 2019

    Report

    Report Number
    3003152976-2019-00755
    Event Type
    Malfunction
    Date Received
    November 4, 2019
    Date of Event
    October 21, 2019
    Report Date
    November 14, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150647
    PMA / PMN Number
    K181221
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: AFTER ADDITIONAL REVIEW, THIS REPORT IS A DUPLICATE REPORT OF MFR # 3003152976-2019-00757. THIS EVENT HAS BEEN OVER-REPORTED AND THE COMPLAINT WILL BE CANCELLED. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA PROTECTOR (P20-O) MEMBRANE HAD "CYCLOPHOSPHAMIDE" RESIDUE ON IT AFTER WITHDRAWING FLUID FROM THE INJECTOR. ADDITIONALLY, IT WAS REPORTED THAT THE PROTECTOR DID NOT EXPAND WHEN INJECTING AIR INTO THE VIAL PRIOR TO WITHDRAWING FLUID, CAUSING THE FLUID TO BE "SUCKED BACK INTO" THE VIAL WHEN ATTEMPTING TO DISCONNECT FROM IT. THIS REPORTEDLY HAPPENED MORE OFTEN WITH "CONCAVE VIAL STOPPERS AND VISCOUS/OILY DRUGS". LOT #'S 1903161 AND 1902153 WERE REPORTED TO HAVE BEEN INVOLVED IN ALL EVENTS, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 6 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ALL THREE P20-0 MEMBRANES OF THE CYCLOPHOSPHAMIDE VIALS HAD RESIDUE AFTER WITHDRAWING FLUID WITH THE N35-0 INJECTOR. THE INFUSION ADAPTER C100-0 HAD RESIDUE AFTER TRANSFERRING THE CYCLOPHOSPHAMIDE INTO THE INFUSION BAG WITH THE SAME N35-0 INJECTOR." "THE DIAPHRAGMS OF THE PHASEAL OPTIMA P20-0 PROTECTORS DID NOT ALWAYS EXPAND WHEN INJECTING AIR INTO THE VIALS WITH THE OPTIMA N35-0 INJECTORS PRIOR TO WITHDRAWING FLUID. THEREFORE, THE PRESSURE IN THE VIALS DID NOT EQUALIZED, CAUSING THE FLUID TO BE SUCKED BACK INTO THE VIALS WHEN TRYING TO DISCONNECT THE SYRINGES FROM THE VIALS. SOMETIMES THE PROTECTOR DIAPHRAGM DID EXPAND, BUT THE PRESSURE WAS STILL NOT EQUALIZED. THIS OCCURRED MOST OFTEN WITH CONCAVE VIAL STOPPERS AND VISCOUS/OILY DRUGS."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1903161. MEDICAL DEVICE EXPIRATION DATE: 2020-02-29. DEVICE MANUFACTURE DATE: 2019-03-25. MEDICAL DEVICE LOT #: 1902153. MEDICAL DEVICE EXPIRATION DATE: 2020-01-31. DEVICE MANUFACTURE DATE: 2019-03-14. 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 THE BD PHASEAL¿ OPTIMA PROTECTOR (P20-O) MEMBRANE HAD "CYCLOPHOSPHAMIDE" RESIDUE ON IT AFTER WITHDRAWING FLUID FROM THE INJECTOR. ADDITIONALLY, IT WAS REPORTED THAT THE PROTECTOR DID NOT EXPAND WHEN INJECTING AIR INTO THE VIAL PRIOR TO WITHDRAWING FLUID, CAUSING THE FLUID TO BE "SUCKED BACK INTO" THE VIAL WHEN ATTEMPTING TO DISCONNECT FROM IT. THIS REPORTEDLY HAPPENED MORE OFTEN WITH "CONCAVE VIAL STOPPERS AND VISCOUS/OILY DRUGS". LOT #'S 1903161 AND 1902153 WERE REPORTED TO HAVE BEEN INVOLVED IN ALL EVENTS, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 6 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ALL THREE P20-0 MEMBRANES OF THE CYCLOPHOSPHAMIDE VIALS HAD RESIDUE AFTER WITHDRAWING FLUID WITH THE N35-0 INJECTOR. THE INFUSION ADAPTER C100-0 HAD RESIDUE AFTER TRANSFERRING THE CYCLOPHOSPHAMIDE INTO THE INFUSION BAG WITH THE SAME N35-0 INJECTOR." "THE DIAPHRAGMS OF THE PHASEAL OPTIMA P20-0 PROTECTORS DID NOT ALWAYS EXPAND WHEN INJECTING AIR INTO THE VIALS WITH THE OPTIMA N35-0 INJECTORS PRIOR TO WITHDRAWING FLUID. THEREFORE, THE PRESSURE IN THE VIALS DID NOT EQUALIZED, CAUSING THE FLUID TO BE SUCKED BACK INTO THE VIALS WHEN TRYING TO DISCONNECT THE SYRINGES FROM THE VIALS. SOMETIMES THE PROTECTOR DIAPHRAGM DID EXPAND, BUT THE PRESSURE WAS STILL NOT EQUALIZED. THIS OCCURRED MOST OFTEN WITH CONCAVE VIAL STOPPERS AND VISCOUS/OILY DRUGS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065299 BD PHASEAL¿ OPTIMA PROTECTOR (P20-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. SEE SECTION H.10. 00382905150647

    Patients

    Seq Age Sex Outcome Treatment
    1 Other