BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7642714 · Received June 27, 2018

    Report

    Report Number
    2134319-2018-00076
    Event Type
    Injury
    Date Received
    June 27, 2018
    Date of Event
    April 8, 2018
    Report Date
    September 11, 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
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    FDA NOTIFIED?: YES. THE FDA WAS MADE AWARE OF THIS INCIDENT VIA VOLUNTARY MEDWATCH 5077738.

    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 2018. CAPA 350041 WAS INITIATED TO ADDRESS THIS ISSUE. THERE WERE NO NON-CONFORMANCES, DEVIATIONS, OR OUT OF SPECIFICATION CONDITIONS NOTED DURING THE MANUFACTURE OF LOT 734211A THAT MAY HAVE CONTRIBUTED TO THE REACTION. 100% OF RETAINED SAMPLES FOR THE LOT (120 UNITS) WERE VISUALLY INSPECTED. NO GROWTH WAS SEEN (I.E., SOLUTION WAS CLEAR). LOT NUMBER 734211A WAS MANUFACTURED BETWEEN LOTS 731012N AND 735311N, 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. 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 USED A 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE ON HER PICC LINE WHICH IS USED TO DONATE STEM CELLS TO HER SISTER AND BECAME ILL WITH A COUGH, HIGH FEVER, AND LOSS OF APPETITE ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT WENT TO AN URGENT CARE WHERE SHE WAS EVALUATED, DIAGNOSED WITH PNEUMONIA, AND GIVEN ANTIBIOTICS. INFORMATION REGARDING THE PATIENT SISTER IS CAPTURED UNDER A SEPARATE MDR REPORT # 2134319-2018-00077. *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 A PATIENT USED A 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE ON HER PICC LINE WHICH IS USED TO DONATE STEM CELLS TO HER SISTER AND BECAME ILL WITH A COUGH, HIGH FEVER, AND LOSS OF APPETITE ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT WENT TO AN URGENT CARE WHERE SHE WAS EVALUATED, DIAGNOSED WITH PNEUMONIA, AND GIVEN ANTIBIOTICS. INFORMATION REGARDING THE PATIENT SISTER IS CAPTURED UNDER A SEPARATE MDR REPORT # 2134319-2018-00077. *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 (B)(6) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE (B)(6) 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 (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483152 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE PREFILLED SALINE FLUSH SYRINGE FOZ BECTON DICKINSON MEDICAL SYSTEMS 734211A 30382903065005

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention