BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7478306 · Received May 1, 2018

    Report

    Report Number
    2134319-2018-00011
    Event Type
    Injury
    Date Received
    May 1, 2018
    Date of Event
    March 2, 2017
    Report Date
    July 12, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FOZ
    PMA / PMN Number
    K011982
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: LOT NUMBERS: 722311C, 722211C, AND 722111C FOR PRODUCT CODE: 306502 WERE PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. UPON REVIEWING THE PRODUCTION HISTORY FOR THE PROVIDED LOT NUMBERS, 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 EACH LOT NUMBER PROVIDED WERE VISUALLY INSPECTED AND NO ABNORMALITIES WERE OBSERVED IN REGARDS TO THE SOLUTION. FORTY RETAINED SAMPLES FOR EACH LOT NUMBER PROVIDED WERE SENT FOR STERILITY TESTING. THE STERILITY TESTING CONFIRMED THAT THE SAMPLES EXHIBITED NO MICROBIAL GROWTH AFTER INCUBATION. A DIRECT CAUSATION BETWEEN THE INFECTIONS AND THE BD FRANKLIN PRODUCT HAS NOT BEEN IDENTIFIED. 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 CONTACTED A SERRATIA MARCESCENS AFTER USING A 5 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE. THE CDC INDICATED PRELIMINARY INFORMATION FROM THE MN PUBLIC HEALTH LAB SHOWS THE PFGE OF THIS ISOLATE IS A MATCH TO THE OUTBREAK STRAIN. THE CDC RECEIVED THIS CLINICAL ISOLATE AND PLAN ON REPEATING THE PFGE AS WELL. AS OF ON (B)(6) 2018 THE FOLLOWING CLINICAL INFORMATION HAS BEEN PROVIDED: THE PATIENT HAS A DOUBLE LUMEN TUNNELED CVC AND RECEIVED NUMEROUS MEDICATIONS VIA A HOME HEALTH AGENCY. THE PATIENT RECEIVED REGULAR TPN FOR SHORT GUT SYNDROME. BLOOD CULTURE DATE ON (B)(6) 2018: POSITIVE FOR S. MARCESCENS. ADMINISTRATION DATES FOR THE FOLLOWING LOT NUMBERS ARE: LOT#: 722211C, 3/2/2018: 60 EACH, 3/23/2018: 60 EACH, 3/30/2018: 60 EACH, LOT#: 722311C, 3/13/2018: 60 EACH, 3/16/2018: 60 EACH, 4/6/2018: 60 EACH, LOT#: 722111C, 4/13/2018: 60 EACH. MN PLANS TO SEND SOME PRODUCT FROM EACH OF THESE LOTS TO CDC FOR TESTING, EXCEPT FOR HEPARIN LOT NUMBER: 721481N (NO REMAINING PRODUCT), AND THIS PRODUCT WAS LAST ADMINISTERED ON (B)(6) 2018.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBER WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 722211C, EXPIRATION DATE: 8/9/2020, MANUFACTURE DATE: 8/14/2017. MEDICAL DEVICE LOT #: 722311C, EXPIRATION DATE: 8/10/2020, MANUFACTURE DATE: 8/14/2017. MEDICAL DEVICE LOT #: 722111C, EXPIRATION DATE: 8/8/2020, MANUFACTURE DATE: 8/9/2017. 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 CONTACTED A SERRATIA MARCESCENS AFTER USING A 5 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE. THE CDC INDICATED PRELIMINARY INFORMATION FROM THE (B)(4) LAB SHOWS THE PFGE OF THIS ISOLATE IS A MATCH TO THE OUTBREAK STRAIN. THE CDC RECEIVED THIS CLINICAL ISOLATE AND PLAN ON REPEATING THE PFGE AS WELL. AS OF (B)(6) 2018 THE FOLLOWING CLINICAL INFORMATION HAS BEEN PROVIDED: - THE PATIENT HAS A DOUBLE LUMEN TUNNELED CVC AND RECEIVED NUMEROUS MEDICATIONS VIA A HOME HEALTH AGENCY. - THE PATIENT RECEIVED REGULAR TPN FOR SHORT GUT SYNDROME. - BLOOD CULTURE DATE (B)(6) 2018: POSITIVE FOR S. MARCESCENS. - ADMINISTRATION DATES FOR THE FOLLOWING LOT NUMBERS ARE: LOT #: 722211C, (B)(6) 2018: 60 EACH, (B)(6) 2018: 60 EACH, (B)(6) 2018: 60 EACH. LOT #: 722311C, (B)(6) 2018: 60 EACH, (B)(6) 2018: 60 EACH, (B)(6) 2018: 60 EACH. LOT #: 722111C, (B)(6) 2018: 60 EACH. (B)(4) PLANS TO SEND SOME PRODUCT FROM EACH OF THESE LOTS TO CDC FOR TESTING, EXCEPT FOR HEPARIN LOT NUMBER 721481N (NO REMAINING PRODUCT), AND THIS PRODUCT WAS LAST ADMINISTERED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318396 5 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE PREFILLED SALINE FLUSH SYRINGE FOZ BECTON DICKINSON MEDICAL SYSTEMS SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention