BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNSPECIFIED BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE

    MDR report key: 7587397 · Received June 11, 2018

    Report

    Report Number
    2134319-2018-00042
    Event Type
    Death
    Date Received
    June 11, 2018
    Date of Event
    March 11, 2018
    Report Date
    June 28, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: AS BOTH A LOT NUMBER AND SAMPLE WERE UNAVAILABLE FOR THIS INCIDENT, A FULL INVESTIGATION CONSISTING OF A SAMPLE ANALYSIS AND A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. PRIOR TO APRIL 2018, THERE WAS NO TREND FOR INFECTION REGARDING THE BD (B)(4) PRODUCTS. UPON THE INCREASE OF INFECTION REPORTS BEGINNING IN APRIL 2018, A CORRECTIVE AND PREVENTIVE ACTION PLAN WAS INITIATED TO ADDRESS THE ISSUE. A REVIEW OF ALL LOT STERILITY TESTING PERFORMED FOR PRODUCT RELEASED BETWEEN APRIL 2015 AND MAY 2018 CONFIRMED THAT NO ORGANISM GROWTH WAS IDENTIFIED FOR ANY LOTS RELEASED DURING THE SHELF LIFE OF THIS PRODUCT. A DIRECT CAUSATION BETWEEN THE REPORTED INFECTIONS AND THE BD (B)(4) PRODUCT HAS NOT BEEN IDENTIFIED. INVESTIGATION CONCLUSION: UNKNOWN ¿ LOT NUMBER WAS NOT PROVIDED PRIOR TO THE REPORT OF INFECTION EVALUATED IN (B)(4), THERE WAS NO TREND FOR INFECTION CASES REPORTED FOR (B)(4) PRODUCT. THIS COMPLAINT IS PART OF A NEW TREND WHICH BEGAN IN APRIL 2018. CAPA (B)(4) WAS INITIATED TO ADDRESS THIS ISSUE. AS NO LOT NUMBER WAS PROVIDED, A DHR REVIEW COULD NOT BE COMPLETED. QUANTITY OF RETAINED SAMPLES USED FOR TESTING: 0 ¿ ALTHOUGH RETAIN SAMPLES ARE AVAILABLE FOR ALL LOTS MANUFACTURED IN (B)(4), AS THE LOT NUMBER WAS NOT PROVIDED, RETAIN SAMPLES WERE NOT TESTED. A REVIEW OF ALL LOT STERILITY TESTING PERFORMED FOR PRODUCT RELEASED BETWEEN APRIL 2015 & MAY 2018 CONFIRMED THAT NO ORGANISM GROWTH WAS IDENTIFIED FOR ANY LOTS RELEASED DURING THE SHELF-LIFE OF THIS PRODUCT. CONCLUSION(S): THE ROOT CAUSE ANALYSIS OF THE REPORTED INFECTION CASES UNDER CAPA (B)(4) HAS NOT IDENTIFIED A DIRECT CAUSATION BETWEEN THE INFECTIONS AND THE BD (B)(4) PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO WAS DIAGNOSED WITH LYMPHOMA AND BEING TREATED WITH CHEMOTHERAPY DEVELOPED THROMBOSIS AND WAS ADMITTED TO A HOSPITAL. THE PATIENT BECAME QUITE ILL IN THE HOSPITAL AND EVENTUALLY PASSED AWAY. THE PATIENT'S FATHER CLAIMED THAT THE CAUSE OF DEATH WAS A BACTERIAL INFECTION THAT HE INDICATED, "NO ONE KNOWS WHERE IT CAME FROM," BUT HE BELIEVES IT IS ASSOCIATED WITH AN UNSPECIFIED BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE THAT WAS USED TWO TIME PER DAY FOR FIVE DAYS. OUT OF AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF PUBLIC HEALTH, BD VOLUNTARILY RECALLED CERTAIN LOTS OF BD POSIFLUSH¿ HEPARIN LOCK FLUSH AND BD¿ PRE-FILLED NORMAL SALINE FLUSH SYRINGES DUE TO A POTENTIAL FOR CONTAMINATION WITH SERRATIA MARCESCENS BACTERIUM. BD WAS NOTIFIED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) AND CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE FDA AND CDC IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECTION IN A SMALL NUMBER OF PATIENTS CAUSED BY S. MARCESCENS ACROSS MULTIPLE STATES. CDC¿S INITIAL INVESTIGATION FOUND THAT AFFECTED PATIENTS HAD RECEIVED TREATMENT USING CERTAIN BD FLUSH PRODUCTS. TO DATE, THERE IS NO EVIDENCE OF BD FLUSH PRODUCT TESTING POSITIVE FOR THIS BACTERIUM. INVESTIGATIONS ARE ONGOING BY BD, FDA, AND CDC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431792 UNSPECIFIED BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE PREFILLED HEPARIN FLUSH SYRINGE FOZ BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Death| H