BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNSPECIFIED BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE

    MDR report key: 7672137 · Received July 9, 2018

    Report

    Report Number
    2134319-2018-00086
    Event Type
    Death
    Date Received
    July 9, 2018
    Date of Event
    April 25, 2018
    Report Date
    August 22, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    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

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 07/03/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: SEX:MALE. EVENT ATTRIBUTED TO: DEATH. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: NO. 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 DEATH AND THE BD (B)(4) PRODUCT HAS NOT BEEN IDENTIFIED. PRIOR TO THE REPORT OF INFECTION EVALUATED IN (B)(4), THERE WAS NO TREND FOR INFECTION OR RELATED CASES REPORTED FOR (B)(4) PRODUCT. THE COMPLAINT IS PART OF A NEW TREND WHICH BEGAN IN APRIL 2018. CAPA (B)(4) WAS INITIATED TO ADDRESS INFECTION AND RELATED CASES. AS A LOT NUMBER WAS NOT PROVIDED, A DHR REVIEW COULD NOT BE COMPLETED. NO SAMPLES OR PICTURES WERE RETURNED. 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. THE ROOT CAUSE ANALYSIS OF THE REPORTED INFECTION AND RELATED 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 HAD VISITED MULTIPLE HOSPITALS FROM (B)(6) 2018 - (B)(6) 2018 FOR BLOOD IN STOOL, LEAKING HEART VALVE, AND FLUID IN HIS LUNGS. THE PATIENT RECEIVED A PICC LINE FOR ANTIBIOTICS AND AN UNSPECIFIED BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE WAS USED EACH DAY FOR ONE WEEK. CULTURES WERE TAKEN AND TESTED POSITIVE, BUT IT IS NOT KNOWN WHAT THE TEST RESULTS SHOWED OR WHAT THE SOURCE OF THE CULTURE WAS. THE PATIENT WAS SEEN BY HIS INFECTIOUS DISEASE DOCTOR IN WHICH IT WAS STATED THAT THE PATIENT¿S HEART VALVES WERE FINE, BUT A WEEK LATER PATIENT WAS RUNNING A SLIGHT FEVER AND SOUNDED AS IF FLUID WAS IN HIS LUNGS PER THE HOME NURSE. THE PATIENT SAW INFECTIOUS DISEASE DOCTOR AGAIN WHO HAD PATIENT TRANSFERRED TO EMERGENCY DEPARTMENT AND WAS TOLD THAT HIS VALVES WERE COMPROMISED AND WOULD NEED TO BE REPLACED. THE PATIENT PASSED AWAY ONE WEEK LATER. THE SPOUSE OF PATIENT STATED THAT CAUSE OF DEATH IS LISTED ON THE DEATH CERTIFICATE AND DID NOT STATE WHAT THE CAUSE OF DEATH WAS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD VISITED MULTIPLE HOSPITALS FROM (B)(6) 2018 - (B)(6) 2018 FOR BLOOD IN STOOL, LEAKING HEART VALVE, AND FLUID IN HIS LUNGS. THE PATIENT RECEIVED A PICC LINE FOR ANTIBIOTICS AND AN UNSPECIFIED BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE WAS USED EACH DAY FOR ONE WEEK. CULTURES WERE TAKEN AND TESTED POSITIVE, BUT IT IS NOT KNOWN WHAT THE TEST RESULTS SHOWED OR WHAT THE SOURCE OF THE CULTURE WAS. THE PATIENT WAS SEEN BY HIS INFECTIOUS DISEASE DOCTOR IN WHICH IT WAS STATED THAT THE PATIENT¿S HEART VALVES WERE FINE, BUT A WEEK LATER PATIENT WAS RUNNING A SLIGHT FEVER AND SOUNDED AS IF FLUID WAS IN HIS LUNGS PER THE HOME NURSE. THE PATIENT SAW INFECTIOUS DISEASE DOCTOR AGAIN WHO HAD PATIENT TRANSFERRED TO EMERGENCY DEPARTMENT AND WAS TOLD THAT HIS VALVES WERE COMPROMISED AND WOULD NEED TO BE REPLACED. THE PATIENT PASSED AWAY ONE WEEK LATER. THE SPOUSE OF PATIENT STATED THAT CAUSE OF DEATH IS LISTED ON THE DEATH CERTIFICATE AND DID NOT STATE WHAT THE CAUSE OF DEATH WAS. *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
    513341 UNSPECIFIED BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE PREFILLED HEPARIN FLUSH SYRINGE FOZ BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death