BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7594808 · Received June 12, 2018

    Report

    Report Number
    2134319-2018-00062
    Event Type
    Injury
    Date Received
    June 12, 2018
    Date of Event
    May 22, 2018
    Report Date
    September 7, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FOZ
    UDI-DI
    30382903065029
    PMA / PMN Number
    K011982
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: PRIOR TO THE REPORT OF INFECTION EVALUATED IN (B)(4), THERE WAS NO TREND FOR INFECTION CASES REPORTED FOR FRANKLIN PRODUCT. THIS COMPLAINT IS PART OF A NEW TREND WHICH BEGAN IN APRIL 2018. CAPA: 350041 WAS INITIATED TO ADDRESS THIS ISSUE. 100% OF RETAINED SAMPLES (B)(4) UNITS) WERE VISUALLY INSPECTED. NO GROWTH WAS SEEN (I.E., SOLUTION WAS CLEAR). LOT: 712411B WAS MANUFACTURED BETWEEN 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 & JUNE 2018 CONFIRMED THAT NO ORGANISM GROWTH WAS IDENTIFIED FOR ANY LOTS RELEASED DURING THE SHELF LIFE OF THIS PRODUCT. A REVIEW OF THE DHR AND SUPPORTING DOCUMENTATION FOR LOT: 712411B WAS PERFORMED. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES OR OUT OF SPECIFICATIONS RELATED TO THE MANUFACTURE OF LOT: 712411B OR THE RAW MATERIALS USED TO MANUFACTURE THIS LOT. 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 A PATIENT CONTACTED AN INFECTION AFTER HAVING HIS APPENDIX REMOVED. THE PATIENT HAD TO HAVE A DRAINAGE TUBE PLACED. THE PATIENT INDICATED THAT 5 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGES, IN 10 ML SYRINGE WERE USED. 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. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 AN INFECTION AFTER HAVING HIS APPENDIX REMOVED. THE PATIENT HAD TO HAVE A DRAINAGE TUBE PLACED. THE PATIENT INDICATED THAT 5 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGES, IN 10 ML SYRINGE WERE USED. 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
    435267 5 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE PREFILLED SALINE FLUSH SYRINGE FOZ BECTON DICKINSON MEDICAL SYSTEMS 712411B 30382903065029

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention