BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7799638 · Received August 20, 2018

    Report

    Report Number
    2134319-2018-00106
    Event Type
    Injury
    Date Received
    August 20, 2018
    Date of Event
    July 26, 2018
    Report Date
    October 1, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    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 FOR FRANKLIN PRODUCT. THESE COMPLAINTS ARE PART OF A NEWT REND WHICH BEGAN IN APRIL 2018. CAPA 350041 WAS INITIATED TO ADDRESS THIS ISSUE 100% OF RETAINED SAMPLES FOR THE TWO REPORTED LOTS (120 UNITS PER LOT) WERE VISUALLY INSPECTED. NO GROWTH WAS SEEN (I.E., THE SOLUTION WAS CLEAR). LOT NUMBERS 729011A AND 729711A WERE BOTH MANUFACTURED BETWEEN TESTED LOTS 726971N AND 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 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 729011A WAS PERFORMED. THERE WERE NO DEVIATIONS, NON-CONFORMANCES, OR OUT OF SPECIFICATIONS RELATED TO THE MANUFACTURE OF LOT 729011A OR THE RAW MATERIALS USED TO MANUFACTURE THIS LOT. A REVIEW OF THE DHR AND SUPPORTING DOCUMENTATION FOR LOT 729711A WAS PERFORMED. THERE WERE NO DEVIATIONS, NON-CONFORMANCES, OR OUT OF SPECIFICATIONS RELATED TO THE MANUFACTURE OF LOT 729711A 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. 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: A.3. SEX: FEMALE. B.2. EVENT ATTRIBUTED TO: REQUIRED INTERVENTION. D.8. DEVICE SINGLE USE?: NO. H.3. DEVICE RETURNED TO MANUFACTURE: NO.

    Description of Event or Problem · 0

    "IT WAS REPORTED THAT A PATIENT WENT TO HER DOCTOR TO RECEIVE AN ABDOMINAL WOULD CULTURE. THE WOULD CULTURE INDICATED THE PATIENT HAD AN INFECTION AND SHE WAS PRESCRIBED DOXYCYCLINE AND PENICILLIN. THE USE OF A 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE 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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. TWO LOT NUMBERS WERE PROVIDED OR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 729011A, EXPIRATION DATE: 10/16/2020, MANUFACTURE DATE: 10/20/2017. MEDICAL DEVICE LOT #: 729711A, EXPIRATION DATE: 10/23/2020, MANUFACTURE DATE: 10/29/2017. 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 WENT TO HER DOCTOR TO RECEIVE AN ABDOMINAL WOULD CULTURE. THE WOULD CULTURE INDICATED THE PATIENT HAD AN INFECTION AND SHE WAS PRESCRIBED DOXYCYCLINE AND PENICILLIN. THE USE OF A 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE 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. (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. (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, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637636 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE PREFILLED SALINE FLUSH SYRINGE FOZ BECTON DICKINSON MEDICAL SYSTEMS SEE H.10. 30382903065005

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention