BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM

    MDR report key: 6429643 · Received March 23, 2017

    Report

    Report Number
    3002807615-2017-00001
    Event Type
    Injury
    Date Received
    March 23, 2017
    Date of Event
    February 21, 2017
    Report Date
    March 23, 2017
    Manufacturer
    TEVA MEDICAL LTD., MIGADA SITE
    Product Code
    ONB
    PMA / PMN Number
    K141448
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2017, SPONTANEOUS, PATIENT/CONSUMER SERIOUS REPORT (LOCAL #(B)(4), PHIT #(B)(4). A CONSUMER/OTHER NON HEALTH PROFESSIONAL REPORTED THE CASE OF A (B)(6) MALE PATIENT WHO RECEIVED FLUOROURACIL (PRODUCT IS OR CANNOT BE EXCLUDED AS A TEVA PRODUCT), TEVADAPTOR DEVICE (PRODUCT IS OR CANNOT BE EXCLUDED AS A TEVA PRODUCT). THE PATIENT TOOK FLUOROURACIL (INTRAVENOUS NOT OTHERWISE SPECIFIED), FROM (B)(6) 2016, 10 MG/HR-THIRD CYCLE), TEVADAPTOR DEVICE (INTRAVENOUS (NOT OTHERWISE SPECIFIED) BATCH: (B)(4). WHILE ON THE SUSPECT MEDICATION(S), THE PATIENT EXPERIENCED SPIKE FOR CHEMO BAG BROKE OFF IN THE BAG PORT (NOT SERIOUS, SINCE (B)(6) 2017); EMOTIONAL DISTRESS (NOT SERIOUS, SINCE (B)(6) 2017); PATIENT WAS INSTRUCTED BY CLINICIAN TO CONTAIN THE CHEMO; CLEANING UP THE SPILL (SERIOUS, SINCE (B)(6) 2017); SKIN IRRITATION OF BOTH HANDS(SERIOUS, SINCE (B)(6) 2017). ON (B)(6) 2017, THE QUALITY ASSURANCE DEPARTMENT RECEIVED NOTIFICATION OF THIS REPORT FROM BBRAUN STATING ¿SPIKE FOR CHEMO BAG BROKE OFF IN THE BAG PORT DURING CONTINUOUS INFUSION OF FLUOROURACIL. PATIENT INJURY, YES. STATED THAT THE SPIKE BROKE OFF IN BAB WHILE INFUSING FLUOROURACIL AT 10ML/HR. ADDITIONAL INFORMATION PROVIED: RESPONSE FROM CUSTOMER INDICATED THAT A (B)(6) MALE WAS INFUSING AT HOME USING TEVADAPTOR REF# (B)(4) AND 500 ML BAG. THEN, 8-12 HOURS AFTER THE START OF INFUSION THE SPIKE BROKE OFF IN THE BAG. THE PATIENT WAS INSTRUCTED BY CLINICIAN TO CONTAIN THE CHEMO TO THE BEST OF HIS ABILITY. REGISTERED NURSE VISITED THE HOME TO HELP CLEAN UP, 4 SKIN IRRITATION OF BOTH HANDS AS HE WAS CLEANING UP THE SPILL. MEDICAL DOCTOR WAS CONTACTED, NO MEDICAL INTERVENTIONS WERE NECESSARY AND THE IRRITATION HAS RESOLVED. CUSTOMER REPORTED THAT THERE WAS NO DIFFICULTY INSERTING THE SPIKE. FIRST ROUND OF CHEMO STARTED (B)(6) 2016 THEN RECEIVES ONE BAG FOR HOME INFUSION EVERY 2 WEEKS THEREAFTER. SPILL HAPPENED DURING HIS THIRD CYCLE. TRAINING PROVIDED BY HOME NURSE AT THE BEGINNING OF EACH CYCLE. SAMPLES WITH CUSTOMER. PICTURES ATTACHED. SAMPLE RETURN EMAIL SENT IN AN ATTEMPT TO OBTAIN SAMPLE. ONCE SAMPLE IS OBTAINED IT WILL BE FORWARDED TO TEVA¿. AT THE TIME OF THE REPORT THE OUTCOME OF THE AES WERE: PATIENT WAS INSTRUCTED BY CLINICIAN TO CONTAIN THE CHEMO; CLEANING UP THE SPILL: UNKNOWN, SKIN IRRITATION OF BOTH HANDS: RECOVERED/RESOLVED. EMOTIONAL DISTRESS: UNKNOWN, SPIKE FOR CHEMO BAG BROKE OFF IN THE BAG PORT: UNKNOWN. ACTION TAKEN WITH SUSPECT DRUGS: FLUOROURACIL UNKNOWN; TEVADAPTOR DEVICE: UNKNOWN. THE PATIENT¿S MEDICAL HISTORY WAS NOT REPORTED. THE PATIENT¿S CONCOMITANT MEDICATION WERE UNSPECIFIED. THE PATIENT¿S PAST MEDICATION WERE UNSPECIFIED. LAB TESTS WERE NOT REPORTED. THIS CASE WAS CONSIDERED SERIOUS BASED ON THE FOLLOWING CRITERIA: (OTHER SERIOUS IMPORTANT MEDICAL EVENTS) TEVA COMMENT: FLUOROURACIL; TEVADAPTOR DEVICE: THIS PATIENT ON HOME TREATMENT WITH FLUOROURACIL EXPERIENCED A DEVICE FAILURE THAT CAUSED A SPILL OF THE PATIENT¿S CHEMOTHERAPY DRUG IN THE PATIENT¿S HOME. AS A RESULT THE PATIENT EXPERIENCED SKIN EXPOSURE TO FLUOROURACIL OVER A FOUR HOUR TIME PERIOD WHILE CLEANING UP THE DRUG SPILL WITHOUT THE BENEFIT OF THE APPROPRIATE SUPPLIES TO HANDLE A DRUG SPILL AND DEVELOPED SKIN IRRITATION AS A RESULT. IN ADDITION THE PATIENT¿S HOME WAS EXPOSED TO A CHEMOTHERAPY DRUG. THIS PATIENT DEVELOPED AN INJURY THAT IS ASSESSED MEDICALLY AS A SERIOUS INJURY DUE TO THE NATURE OF THE DRUG EXPOSED, AND THE DURATION OF EXPOSURE. EVEN THOUGH THIS PATIENT¿S SKIN EVENT WAS REPORTED TO RESOLVE, IT DOES NOT NEGATE THE POTENTIAL LONG TERM EFFECTS OF SUCH A PROLONGED DRUG EXPOSURE TO A CHEMOTHERAPEUTIC DRUG. THIS IS A SITUATION INVOLVING A MEDICAL DEVICE FAILURE THAT WOULD RESULT IN SIMILAR IF NOT WORSE CONSEQUENCES SHOULD IT REOCCUR. THE REPORTED EVENT OF SKIN IRRITATION IS ASSESSED AS ¿HIGHLY PROBABLE¿ TO FLUOROURACIL AND NOT RELATED TO THE TEVADAPTOR DEVICE USED TO ADMINISTER THE PATIENT¿S CHEMOTHERAPY. THE EVENTS ¿SPIKE FOR CHEMO BAG BROKE OFF IN THE BAG PORT¿, ¿EMOTIONAL DISTRESS¿, AND ¿PATIENT WAS INSTRUCTED BY CLINICIAN TO CONTAIN THE CHEMO; CLEANING UP THE SPILL¿ ARE ALL ASSESSED AS NOT RELATED TO FLUOROURACIL AND ¿HIGHLY PROBABLE¿ TO THE TEVADAPTOR DEVICE USED TO ADMINISTER THE PATIENT¿S CHEMOTHERAPY. BECAUSE THIS IS A SPONTANEOUS CASE, REGULATORY DISTRIBUTION WILL BE HANDLED AS THOUGH IT IS A RELATED CASE. ON 27-FEB-2017, ADDITIONAL INFORMATION RECEIVED FROM BBRAUN; THERAPY WAS INTERRUPTED FOR 4 HOURS, BUT THE ORDERED DOSE WAS COMPLETED. REPLACEMENT BAG THERAPY WAS INTERRUPTED FOR 4 HOURS, BUT THE ORDERED DOSE WAS COMPLETED. REPLACEMENT BAG WAS SENT AFTER DISCOVERY OF THE LEAK AND THE REMAINDER OF THE DOSE WAS GIVEN SUCCESSFULLY. PATIENT TOSSED BACKPACK AND RUG THAT CONTAINED THE CHEMO SPILL. THE HARDWOOD FLOOR AND AMBULATORY PUMP WAS CLEANED PRIOR TO REGISTERED NURSE LEAVING THE HOME. THE MEDICAL DOCTOR WAS NOTIFIED WITHOUT ADDITIONAL FOLLOW UP VISIT SCHEDULED. PATIENT WAS SEEN 2 WEEKS LATER DURING A PREVIOUSLY SCHEDULED VISIT. PATIENT NOTICED HANDS WERE TINGLING WHEN HE TRIED TO CLEAN UP THE CHEMO SPILL. HE PROMPTLY WASHED HIS HANDS AND DONNED ON GLOVES TO FINISH UP THE CLEANING. NO PERMANENT HARM INCURRED. TEVA COMMENT: THE NEW ADVERSE EVENT OF HANDS TINGLING IS ASSESSED AS ¿HIGHLY PROBABLE¿ FOR FLUOROURACIL AND NOT RELATED TO THE TEVADAPTOR DEVICE. FOLLOW-UP INFORMATION DOES NOT CHANGE THE INITIAL ASSESSMENT OF ¿HIGHLY PROBABLE¿ TO FLUOROURACIL AND NOT RELATED TO THE TEVADAPTOR DEVICE USED TO ADMINISTER THE PATIENT¿S A CHEMOTHERAPY FOR THE EVENT SKIN IRRITATION, AND ¿NOT RELATED¿ TO FLUOROURACIL AND ¿HIGHLY PROBABLE¿ TO THE TEVADAPTOR DEVICE USED TO ADMINISTER THE PATIENT¿S CHEMOTHERAPY FOR THE EVENTS ¿SPIKE FOR CHEMO BAG BROKE OFF IN THE BAG PORT¿, ¿EMOTIONAL DISTRESS¿, AND ¿PATIENT WAS INSTRUCTED BY CLINICIAN TO CONTAIN THE CHEMO; CLEANING UP THE SPILL¿. ON (B)(6) 2017, ADDITIONAL INFORMATION WAS PROVIDED FROM THE QUALITY INVESTIGATION FOR TEVADAPTOR. THE ACTUAL DEFECTIVE PRODUCT WAS NOT PROVIDED, ONLY A PHOTO WAS SENT BY B. BRAUN. BY REVIEWING THE PHOTO A SIGN OF BREAKAGE IS CLEARLY VISIBLE. THE BREAKAGE APPEARS TO BE DUE TO A FORCE THAT WAS INFLICTED ON THE SPIKE WHILE INSIDE THE INFUSION BAG. THERE ARE NO SIGNS OF CHEMICAL REACTION BETWEEN THE SPIKE AND THE 5FU MEDICATION. IT APPEARS THAT THE SPIKE WAS INSERTED TOO DEEP, PASSING THE STOPPER ON THE SPIKE. RESERVED SAMPLE REVIEW: VISUAL EXAMINATION: TWO PRODUCTS WERE INSPECTED. THE SPIKES WERE INTACT WITHOUT ANY SIGNS OF DAMAGE. FUNCTIONAL EXAMINATION: AN EXPERIMENT WAS CONDUCTED BY THE MS&T DEPARTMENT: THE SPIKE FOR BAG (SFB) WAS INSERTED INTO AN INFUSION BAG WITH FLUOROURACIL DILUTED IN SALINE. THE PRODUCT WAS LEFT IN THE BAG FOR A PERIOD OF 7 DAYS. NO LEAKAGES OR BREAKAGES WERE OBSERVED ON THE SFB. FROM THE EXAMINATION T CAN BE CONCLUDED THAT THE RESERVED SAMPLE CONFORMS TO THE PRODUCT INTENDED USE. MEDICATION USED: FLUOROURACIL. THE CAP ON THE SPIKE IS PALCED BY THE MANUFACTURER OF THE SPIKE. IN ANY PART OF THE MANUFACTURING OF THE SET, NO IMPACT IS INFLICTED TO THE SPIKE. ACCORDING TO THE MANUFACTURER OF THE SPIKE, DURING PRODUCTION AND INSPECTION THEY DID NOT ENCOUNTER WITH MICRO-FEATURES ON THE PRODUCTS ADDITIONAL INFORMATION FROM THE COMPLAINANT IT WAS THE FIRST TIME THE CONNECTING SET WAS CONNECTED TO A BAG. THE PHARMACY TECHNICIAN WHO MIXED THE COMPOUND SPIKED THE INFUSION BAG. THE INFUSION BAG AND CONNECTING SET WERE STORED BEFORE USE UNDER CONTROLLED CONDITION AT ROOM TEMP IN THE BOX PROVIDED BY THE MANUFACTURER. IT IS UNKNOWN WHETHER THE INFUSION BAG RECEIVE IMPACT FROM ANYTHING. NOT SURE WHAT HAD HAPPENED AFTER PATIENT RECEIVED THE BAG. DID THE BREAKAGE HAPPEN WHILE THE BAG WAS HUNG OR DURING TRANSPORTATION BY THE PATIENT? NEITHER. REGISTERED NURSE WAS IN THE HOME TO CONNECT THE PATIENT. WHEN REGISTERED NURSE LEFT THE PATIENT¿S HOME IT WAS IN WORKING CONDITION. COMMENTS ON HOME USE OF THE PRODUCT: ON THE SINGLE PACKAGE OF THE PRODUCT AND ON THE IFU, THERE IS A VISIBLE RX SIGN, MEANING TO BE PRESCRIBED BY A MEDICAL PERSONNEL ONLY (SEE APPENDIX NO. 11: SINGLE PACKAGE PRINTING AND IFU). IN ADDITION, IN THE ABBREVIATED 510(K) PREMARKET NOTIFICATION FOR THE TEVADAPTOR PRODUCTS, SUBMITTED ON (B)(6) 2014. IT IS STARTED: ¿IT IS COMMON PRACTICE IN HEALTHCARE FACILITIES TO HAVE PARENTERAL DRUGS RECONSTITUTED AND COMPOUNDED INTO INFUSION OR INJECTION CONTAINERS ACCORDING TO SPECIFIC PHYSICIAN¿S PRESCRIPTIONS. THOSE OPERATIONS ARE NORMALLY PERFORMED IN COMPOUNDING CENTERS, BY OR UNDER THE SUPERVISION OF A PHARMACIST, OR IN THE WARDS BY AUTHORIZED HEALTHCARE PERSONNEL¿ (SEE APPENDIX NO. 12: ABBREVIATED 510(K) PREMARKET NOTIFICATION FOR THE TEVADAPTOR PRODUCTS). FOR HOME CARE, TYPICALLY THE HOME CARE AGENCY (IN THIS CASE (B)(6) FILLS OUT THE CONTAINERS THAT WILL BE USED FOR INFUSION AND SENDS TO THE PATIENT HOME A PACKAGE WITH ALL NECESSARY SUPPLIES FOR ALL INFUSIONS. IN THIS PARTICULAR CASE, THE PHARMACY AT (B)(6) COMPOUND (MIXED) THE DRUG IN THE IV BAG, SPIKED THE BAG WITH ONGUARD AND SENT THEM HOME TO BE INFUSED (THE PATIENT DID NOT SPIKE THE BAG). THE (B)(6) HOME CARE NURSE INITIATED THE INFUSION TO THE PATIENT AND BEFORE SHE LEFT EVERYTHING WAS WORKING FINE. NO ISSUES. AFTER THE NURSE LEFT THE PATIENT NOTICED THE BREAKAGE OF THE PRODUCT DURING THE INFUSION AND NOTIFIED THE NURSE, WHO INSTRUCTED THE PATIENT TO CLEAN THE SPILL. A NOTIFICATION TO MANAGEMENT WAS SENT. DESCRIPTION OF THE COMPLAINT: BROKEN SPIKE FOR BAG. ACCORDING TO THE INVESTIGATION, THE CONCLUSION IS THAT THE MALFUNCTION PROBABLY OCCURRED DUE TO AN IMPACT THAT WAS INFLICTED TO THE SPIKE PORT ADAPTOR, RESULTED IN BREAKAGE. CORRECTIVE ACTIONS ARE NOT REQUIRED. THE ASSESSMENT OF THE RISKS ASSOCIATED WITH THE MALFUNCTION OF THE PRODUCT IS THAT DEATH OR SERIOUS INJURY ARE HIGHLY UNLIKELY TO OCCUR AS A RESULT OF A USER OR OTHER PERSON AS A RESULT OF THE DEVICE MALFUNCTION. ACCORDING TO THE COMPLAINTS RECEIVED TO DATE AND THE RISK ASSESSMENT THERE IS NO NEED TO TAKE ANY FIELD CORRECTIVE ACTION TO REMOVE DEVICES FROM THE MARKET AT THIS TIME. WE WILL CONTINUE MONITORING THE COMPLAINTS AND EFFECTIVENESS OF THE CORRECTIVE AND PREVENTIVE ACTI

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211427 TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB TEVA MEDICAL LTD., MIGADA SITE M7966E16

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other