BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR N35-O

    MDR report key: 12253936 · Received July 30, 2021

    Report

    Report Number
    3003152976-2021-00437
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    July 1, 2021
    Report Date
    September 20, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 2102302 D4: MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H4: DEVICE MANUFACTURE DATE: UNKNOWN D4: MEDICAL DEVICE LOT #: 2101318 D4: MEDICAL DEVICE EXPIRATION DATE: 2022-03-31 H4: DEVICE MANUFACTURE DATE:2021-02-04 D4: MEDICAL DEVICE LOT #: 2101316 D4: MEDICAL DEVICE EXPIRATION DATE: 2022-03-31 H4: DEVICE MANUFACTURE DATE: 2021-01-29 D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-11-02 H6: INVESTIGATION SUMMARY EIGHT PHASEAL OPTIMA INJECTOR SAMPLES WERE RECEIVED BY THE CUSTOMER FOR THE INVESTIGATION OF THE EVENT REPORTED. ALL SAMPLES WERE UNUSED INSIDE THE UNITARY PACKAGING COMPLETELY SEALED. SAMPLES FROM FOLLOWING LOTS WERE RECEIVED: 1 SAMPLES FROM OPTIMA INJECTOR N35-O LOT 2101308, 1 SAMPLE FROM OPTIMA INJECTOR N35-O LOT 2101318. 1 SAMPLE FROM OPTIMA INJECTOR N35-O LOT 2012309, 1 SAMPLE FROM OPTIMA INJECTOR N35-O LOT 2102302, 3 SAMPLES FROM OPTIMA INJECTOR N35-O LOT 2101316, 1 SAMPLE FROM OPTIMA INJECTOR N35-O LOT 2101311. ACTUAL LOT INVOLVED UNKNOWN. SUSPECTED LOTS 2102302, 2101318, 2101316: ALTHOUGH LOT NUMBER IS UNKNOWN, SUSPECTED LOTS PROVIDED WERE INVESTIGATED. AFTER A VISUAL INSPECTION OF ALL SAMPLES RECEIVED BY THE CUSTOMER, NO ANOMALIES, DAMAGES OR BREAKAGES WERE OBSERVED ON SAMPLES AFTER BEING OPENED THE UNITARY PACKAGES AND OBSERVED THE CLAIMED SAMPLES UNDER MICROSCOPE (X30). FUNCTIONAL TESTING WAS PERFORMED, PENETRATING THE INJECTOR ALONG WITH A SAMPLE SYRINGE AND MATING COMPONENTS TEN TIMES, ALL RESULTS WERE FOUND TO BE ACCEPTABLE WITH NO LEAKS IDENTIFIED. AFTER MULTIPLE CONNECTIONS, NO ANOMALIES , DAMAGES OR BREAKAGES WERE OBSERVED ON THE LUER HUB FROM OPTIMA INJECTORS RECEIVED. COLORANT COULD BE ASPIRATED WITHOUT ANOMALY AND NO LEAKAGE OCCURRED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR SUSPECTED LOTS 2102302, 2101318, AND 2101316, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS, INCLUDING TESTING TO VERIFY ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION SUCH AS THE LUER THREADING. ALL RECORDS WERE REVIEWED FOR THE REPORTED LOT AND RESULTS WERE FOUND TO BE ACCEPTABLE. RETAINED SAMPLES FROM SUSPECTED LOTS 2102302, 2101318, AND 2101316 WERE USED FOR ADDITIONAL EVALUATION, NO DAMAGE WAS OBSERVED ON THE PRODUCT AND ALL LUER DIMENSIONS WERE VERIFIED TO BE WITHIN THE REQUIRED SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. IT IS IMPORTANT TO ENSURE ALL LUER CONNECTIONS ARE SECURELY TIGHTENED BEFORE USE. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INJECTOR N35-O BROKE AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE HEALTH PROFESSIONAL THE N-35O INJECTOR BROKE AT THE THREADING AND LEAKED THROUGH A CRACK IN THE PHASEAL INJECTOR.   VERBATIM: I SPOKE WITH THE STAFF MEMBERS DIRECTLY INVOLVED WITH THE CHEMO SPILL INCIDENT TODAY. LONG STORY SHORT, WE HAD A COMPONENT OF OUR CLOSED SYSTEM TRANSFER DEVICE (CSTD) INJECTOR BREAK. OUR TEAM REPORTS THAT THE COMPONENT CRACKED ALLOWING DOXORUBICIN LIQUID TO LEAK AND SPRAY THROUGH THE CRACK WHEN BEING SUCTIONED FROM THE DRUG VIAL INTO THE SYRINGE. THE TEAM DISPOSED OF THE PIECE ALONG WITH THE SPILL CLEAN-UP MATERIALS SO UNFORTUNATELY, IT IS NOT RETRIEVABLE AT THIS TIME BUT WE WILL BE DOCUMENTING THIS INCIDENT IN HERO AND REPORTING IT TO THE CSTD MANUFACTURER. THIS IS MY FIRST ENCOUNTER WITH THIS SPECIFIC MALFUNCTION IN MY 5+ YEARS WORKING IN ONCOLOGY PHARMACY. THE STAFF DIRECTLY INVOLVED REPORTS BEING A BIT SHAKEN BUT OTHERWISE OKAY. ALL PPE WAS USED APPROPRIATELY TO PROTECT THE STAFF FROM DIRECT EXPOSURE (NEGATIVE PRESSURE HOODS WITH PROTECTIVE GLASS, NEGATIVE PRESSURE BUFFER ROOMS CONTAINING AEROSOLS, DOUBLE GOWNS W/ CHEMO PROTECTION, AND DOUBLE GLOVES W/ CHEMO PROTECTION). COMPOUNDING OPERATIONS WERE IMMEDIATELY HALTED AND TRANSITIONED TO THE MAIN PHARMACY WHILE CLEANING PROCEDURES TOOK PLACE. THE SPILL AND ALL AFFECTED SITES/SURFACES (INCLUDING THE WALLS AND FLOORS) WERE DEACTIVATED, DECONTAMINATED, AND CLEANED USING APPROPRIATE PRODUCTS AND PROCEDURES. AFTER CLEANING, WE REPLACED THE KEYBOARD ON THE AFFECTED COMPUTER SINCE THOROUGHLY CLEANING THE CRACKS AND CREVICES OF THAT DEVICE WAS NOT FEASIBLE. ONCE CLEANING PROCEDURES WERE COMPLETED, WE SAFELY RESUMED COMPOUNDING OPERATIONS IN THAT SPACE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INJECTOR N35-O BROKE AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE HEALTH PROFESSIONAL THE N-35O INJECTOR BROKE AT THE THREADING AND LEAKED THROUGH A CRACK IN THE PHASEAL INJECTOR.   VERBATIM: I SPOKE WITH THE STAFF MEMBERS DIRECTLY INVOLVED WITH THE CHEMO SPILL INCIDENT TODAY. LONG STORY SHORT, WE HAD A COMPONENT OF OUR CLOSED SYSTEM TRANSFER DEVICE (CSTD) INJECTOR BREAK. OUR TEAM REPORTS THAT THE COMPONENT CRACKED ALLOWING DOXORUBICIN LIQUID TO LEAK AND SPRAY THROUGH THE CRACK WHEN BEING SUCTIONED FROM THE DRUG VIAL INTO THE SYRINGE. THE TEAM DISPOSED OF THE PIECE ALONG WITH THE SPILL CLEAN-UP MATERIALS SO UNFORTUNATELY, IT IS NOT RETRIEVABLE AT THIS TIME BUT WE WILL BE DOCUMENTING THIS INCIDENT IN HERO AND REPORTING IT TO THE CSTD MANUFACTURER. THIS IS MY FIRST ENCOUNTER WITH THIS SPECIFIC MALFUNCTION IN MY 5+ YEARS WORKING IN ONCOLOGY PHARMACY. THE STAFF DIRECTLY INVOLVED REPORTS BEING A BIT SHAKEN BUT OTHERWISE OKAY. ALL PPE WAS USED APPROPRIATELY TO PROTECT THE STAFF FROM DIRECT EXPOSURE (NEGATIVE PRESSURE HOODS WITH PROTECTIVE GLASS, NEGATIVE PRESSURE BUFFER ROOMS CONTAINING AEROSOLS, DOUBLE GOWNS W/ CHEMO PROTECTION, AND DOUBLE GLOVES W/ CHEMO PROTECTION). COMPOUNDING OPERATIONS WERE IMMEDIATELY HALTED AND TRANSITIONED TO THE MAIN PHARMACY WHILE CLEANING PROCEDURES TOOK PLACE. THE SPILL AND ALL AFFECTED SITES/SURFACES (INCLUDING THE WALLS AND FLOORS) WERE DEACTIVATED, DECONTAMINATED, AND CLEANED USING APPROPRIATE PRODUCTS AND PROCEDURES. AFTER CLEANING, WE REPLACED THE KEYBOARD ON THE AFFECTED COMPUTER SINCE THOROUGHLY CLEANING THE CRACKS AND CREVICES OF THAT DEVICE WAS NOT FEASIBLE. ONCE CLEANING PROCEDURES WERE COMPLETED, WE SAFELY RESUMED COMPOUNDING OPERATIONS IN THAT SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152194 INJECTOR N35-O INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1