BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 7684428 · Received July 12, 2018

    Report

    Report Number
    2134319-2018-00094
    Event Type
    Injury
    Date Received
    July 12, 2018
    Date of Event
    May 10, 2018
    Report Date
    September 18, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: NO.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: PRIOR TO THE REPORT OF INFECTION EVALUATED IN MPS-18-1248-SA, THERE WAS NO TREND FOR INFECTION CASES REPORTED FOR FRANKLIN PRODUCT. THIS COMPLAINT IS PART OF A NEW TREND WHICH BEGAN IN APRIL 201. CAPA 350041 WAS INITIATED TO ADDRESS THIS ISSUE. DHR: N/A - NO LOT. SAMPLES AND/OR PICTURES WERE NOT PROVIDED FOR EVALUATION. A REVIEW OF ALL LOT STERILITY TESTING PERFORMED FOR PRODUCT RELEASED BETWEEN APRIL 2015 & JUNE 2018 CONFIRMED THAT NO ORGANISM GROWTH WAS IDENTIFIED FOR ANY LOTS RELEASED DURING THE SHELF-LIFE OF THIS PRODUCT. INVESTIGATION CONCLUSION: THE ROOT CAUSE ANALYSIS OF THE REPORTED INFECTION CASES UNDER CAPA 350041 HAS NOT IDENTIFIED A DIRECT CAUSATION BETWEEN THE INFECTIONS AND THE BD FRANKLIN PRODUCT. CAPA 350041 HAS BEEN INITIATED FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN 11 YEAR OLD PATIENT WITH A PORT WHO WAS DIAGNOSED WITH AML TESTED POSITIVE FOR SERRATIA (B)(6) 2018. AN UNSPECIFIED BD POSIFLUSH¿ NORMAL SALINE SYRINGE WAS ASSOCIATED 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 · 0

    HOLD 4.12 ITIT WAS REPORTED THAT AN 11 YEAR OLD PATIENT WITH A PORT WHO WAS DIAGNOSED WITH AML TESTED POSITIVE FOR SERRATIA MAY 10, 2018. AN UNSPECIFIED BD POSIFLUSH¿ NORMAL SALINE SYRINGE WAS ASSOCIATED 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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN (B)(6) YEAR OLD PATIENT WITH A PORT WHO WAS DIAGNOSED WITH AML TESTED (B)(6) FOR (B)(6) (B)(6) 2018. AN UNSPECIFIED BD POSIFLUSH¿ NORMAL SALINE SYRINGE WAS ASSOCIATED 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 (B)(6) FOR THIS (B)(6). INVESTIGATIONS ARE ONGOING BY BD, FDA, AND CDC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526363 UNSPECIFIED BD POSIFLUSH¿ NORMAL SALINE SYRINGE PREFILLED SALINE FLUSH SYRINGE FOZ BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other