BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7537568 · Received May 23, 2018

    Report

    Report Number
    2134319-2018-00031
    Event Type
    Injury
    Date Received
    May 23, 2018
    Date of Event
    May 11, 2018
    Report Date
    August 6, 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
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: LOT: 730311D, THE COMPLAINT IS PART OF A NEW TREND WHICH BEGAN IN APRIL 2018. CAPA 350041 WAS INITIATED TO ADDRESS THIS ISSUE. PRIOR TO THE REPORT OF INFECTION EVALUATED IN MPS-18-1248-SA, THERE WAS NO TREND FOR INFECTION CASES REPORTED FOR FRANKLIN PRODUCT. THERE WERE NO DEVIATIONS, NON-CONFORMANCES, OR OUT OF SPECIFICATION CONDITIONS NOTED DURING THE MANUFACTURE OF LOT 730311D 100% OF RETAINED SAMPLES FOR THE LOT (120 UNITS) WERE VISUALLY INSPECTED. NO GROWTH WAS SEEN (I.E., THE SOLUTION WAS CLEAR). VARIOUS LOTS WERE SENT FOR INCUBATION, THE RETAINED SAMPLES FROM ALL OF THOSE LOTS EXHIBITED NO MICROBIAL GROWTH. LOT 730311D WAS MANUFACTURED BETWEEN TESTED LOTS 726971N & 731012N, 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS HOSPITALIZED WITH A BACTERIAL KIDNEY INFECTION AFTER USING A 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE. THE PATIENT USED THE BD PRODUCT SOMETIME IN FEBRUARY AND WAS HOSPITALIZED IN MARCH. THERE WERE THREE DIFFERENT ORGANISMS IDENTIFIED AT THE TIME. 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

    DATE OF EVENT: UNKNOWN. 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 A PATIENT WAS HOSPITALIZED WITH A BACTERIAL KIDNEY INFECTION AFTER USING A 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE. THE PATIENT USED THE BD PRODUCT SOMETIME IN (B)(6) AND WAS HOSPITALIZED IN (B)(6). THERE WERE THREE DIFFERENT ORGANISMS IDENTIFIED AT THE TIME. 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 (B)(4) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE FDA AND (B)(4) IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECTION IN A SMALL NUMBER OF PATIENTS CAUSED BY S. MARCESCENS ACROSS MULTIPLE STATES. (B)(4)¿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 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379762 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE PREFILLED SALINE FLUSH SYRINGE FOZ BECTON DICKINSON MEDICAL SYSTEMS 730311D 30382903065005

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization