BEUDAMED
    FDA Adverse Event Death Summary report: N

    10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE

    MDR report key: 7550747 · Received May 29, 2018

    Report

    Report Number
    2134319-2018-00032
    Event Type
    Death
    Date Received
    May 29, 2018
    Date of Event
    February 4, 2018
    Report Date
    September 18, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FOZ
    UDI-DI
    30382903065005
    PMA / PMN Number
    K011982
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: LOT NUMBER 715911C FOR PRODUCT CODE 306500 WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. UPON REVIEWING THE PRODUCTION HISTORY FOR THE PROVIDED LOT NUMBER, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. A CORRECTIVE AND PREVENTIVE ACTION PLAN WAS INITIATED TO FURTHER INVESTIGATE AND MONITOR THIS ISSUE. ONE-HUNDRED AND TWENTY RETAINED SAMPLES FOR THE LOT NUMBER PROVIDED WERE VISUALLY INSPECTED AND NO ABNORMALITIES WERE OBSERVED IN REGARDS TO THE SOLUTION. A REVIEW OF ALL LOT STERILITY TESTING PERFORMED FOR PRODUCT RELEASED BETWEEN APRIL 2015 AND JUNE 2018 CONFIRMED THAT NO ORGANISM GROWTH WAS IDENTIFIED FOR ANY LOTS RELEASED DURING THE SHELF-LIFE OF THIS PRODUCT. MULTIPLE SAMPLES PRODUCED BEFORE AND AFTER THE PROVIDED LOT NUMBER WERE SENT FOR STERILITY TESTING AND CONFIRMED THAT NO MICROBIAL GROWTH WAS EXHIBITED AFTER INCUBATION. THIS IN COMBINATION WITH THE DAILY ENVIRONMENTAL MONITORING AND STERILITY TESTING PROVIDES CONFIDENCE IN THE STERILITY OF THE REPORTED LOT NUMBER. 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 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. DHR: THERE WERE NO DEVIATIONS, NON-CONFORMANCES, OR OUT OF SPECIFICATION CONDITIONS RELATED TO THE MANUFACTURE OF LOT 715911C 120 RETAINED SAMPLES WERE 100% VISUALLY INSPECTED. NO GROWTH WAS SEEN (I.E., SOLUTION WAS CLEAR). LOT 715911C WAS MANUFACTURED BETWEEN TESTED LOTS 705311B AND 716192N, BOTH OF WHICH EXHIBITED NO GROWTH DURING THE CONFIRMATORY STERILITY TESTING. THIS, IN COMBINATION WITH THE DAILY ENVIRONMENTAL MONITORING AND ORIGINAL STERILITY TESTING FOR THE LOT RELEASE, PROVIDES CONFIDENCE IN THE STERILITY OF THE COMPLAINT LOT. A REVIEW OF ALL LOT STERILITY TESTING PERFORMED FOR PRODUCT RELEASED BETWEEN APRIL 2015 AND JUNE 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 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

    A CONSUMER REPORTED THAT HER SISTER HAD AN INFECTION AND PASSED AWAY ON (B)(6) 2018. A 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE WAS IMPLICATED WITH THIS INCIDENT. 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

    A CONSUMER REPORTED THAT HER SISTER HAD AN INFECTION AND PASSED AWAY ON (B)(6) 2018. A 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE WAS IMPLICATED WITH THIS INCIDENT. *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
    393648 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE PREFILLED SALINE FLUSH SYRINGE FOZ BECTON DICKINSON MEDICAL SYSTEMS 715911C 30382903065005

    Patients

    Seq Age Sex Outcome Treatment
    1 Death