BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10 ML SYRINGE

    MDR report key: 7696187 · Received July 17, 2018

    Report

    Report Number
    2134319-2018-00103
    Event Type
    Injury
    Date Received
    July 17, 2018
    Date of Event
    May 10, 2018
    Report Date
    August 27, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FOZ
    UDI-DI
    30382903065258
    PMA / PMN Number
    K011967
    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. INVESTIGATION SUMMARY: LOT NUMBERS: 728212N AND 724891N FOR PRODUCT CODE: 306525 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 THE LOT NUMBERS PROVIDED WERE VISUALLY INSPECTED AND NO ABNORMALITIES WERE OBSERVED IN REGARDS TO THE SOLUTION. 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. MULTIPLE SAMPLES PRODUCED BEFORE AND AFTER THE PROVIDED LOT NUMBERS WERE SENT FOR STERILITY TESTING AND CONFIRMED THAT NO MICROBIAL GROWTH WAS EXHIBITED AFTER INCUBATION. THIS IN COMBINATION WITH THE DAILY ENVIRONMENTAL MONITORING AND STERILITY TESTING PROVIDES CONFIDENCE IN THE STERILITY OF THE REPORTED LOT NUMBERS. A DIRECT CAUSATION BETWEEN THE REPORTED INFECTIONS AND THE BD FRANKLIN PRODUCT HAS NOT BEEN IDENTIFIED. 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. (B)(4) RETAINED SAMPLE UNITS WERE 100% VISUALLY INSPECTED FOR EACH LOT. NO GROWTH WAS SEEN (I.E., THE SOLUTION WAS CLEAR). LOT NUMBER: 724891N WAS MANUFACTURED BETWEEN LOTS: 724291N AND 725181N, AND LOT NUMBER: 728212N WAS MANUFACTURED BETWEEN LOTS: 726971N AND 731012N, BOTH OF WHICH EXHIBITED NO GROWTH DURING THE CONFIRMATORY STERILITY TESTING. THIS, IN COMBINATION WITH THE DAILY ENVIRONMENTAL MONITORING AND THE ORIGINAL STERILITY TESTING FOR THE LOT RELEASE, PROVIDES CONFIDENCE IN THE STERILITY OF THE COMPLAINT LOTS. 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: 728212N AND LOT: 724891N WAS PERFORMED. THERE WERE NO DEVIATIONS, NON-CONFORMANCES, OR OUT OF SPECIFICATIONS RELATED TO THE MANUFACTURE OF EITHER LOT OR THE RAW MATERIALS USED TO MANUFACTURE THESE LOTS. 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 69 YEAR OLD PATIENT WITH A PORT WHO HAD BEEN DIAGNOSED WITH CNS LYMPHOMA TESTED POSITIVE FOR SERRATIA ON (B)(6) 2018. A 5 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10 ML SYRINGE WITH BD¿ BLUNT PLASTIC CANNULA 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

    TWO LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 724891N, EXPIRATION DATE: 3/4/2019, MANUFACTURE DATE: 9/19/2017. MEDICAL DEVICE LOT #: 728212N, EXPIRATION DATE: 4/8/2019, MANUFACTURE DATE: 10/13/2017. 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 (B)(6) YEAR OLD PATIENT WITH A PORT WHO HAD BEEN DIAGNOSED WITH CNS LYMPHOMA TESTED POSITIVE FOR SERRATIA ON (B)(6) 2018. A 5 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10 ML SYRINGE WITH BD¿ BLUNT PLASTIC CANNULA 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 (B)(4) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE (B)(4) 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, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535189 5 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10 ML SYRINGE PREFILLED HEPARIN FLUSH SYRINGE FOZ BECTON DICKINSON MEDICAL SYSTEMS SEE H.10. 30382903065258

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other