BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7467627 · Received April 27, 2018

    Report

    Report Number
    2134319-2018-00004
    Event Type
    Injury
    Date Received
    April 27, 2018
    Date of Event
    April 13, 2018
    Report Date
    June 28, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FOZ
    UDI-DI
    30382903065104
    PMA / PMN Number
    K011967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: AS BOTH A LOT NUMBER AND SAMPLE WERE UNAVAILABLE FOR THIS INCIDENT, A FULL INVESTIGATION CONSISTING OF A SAMPLE ANALYSIS AND A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. PRIOR TO APRIL 2018, THERE WAS NO TREND FOR INFECTION REGARDING THE BD FRANKLIN PRODUCTS. UPON THE INCREASE OF INFECTION REPORTS BEGINNING IN APRIL 2018, A CORRECTIVE AND PREVENTIVE ACTION PLAN WAS INITIATED TO ADDRESS THE ISSUE. A REVIEW OF ALL LOT STERILITY TESTING PERFORMED FOR PRODUCT RELEASED BETWEEN APRIL 2015 AND MAY 2018 CONFIRMED THAT NO ORGANISM GROWTH WAS IDENTIFIED FOR ANY LOTS RELEASED DURING THE SHELF LIFE OF THIS PRODUCT. A DIRECT CAUSATION BETWEEN THE REPORTED INFECTIONS AND THE BD FRANKLIN PRODUCT HAS NOT BEEN IDENTIFIED. INVESTIGATION CONCLUSION: UNKNOWN ¿ LOT NUMBER WAS NOT PROVIDED. 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. (B)(4) WAS INITIATED TO ADDRESS THIS ISSUE. AS NO LOT NUMBER WAS PROVIDED, A DHR REVIEW COULD NOT BE COMPLETED. QUANTITY OF RETAINED SAMPLES USED FOR TESTING: 0 ¿ ALTHOUGH RETAIN SAMPLES ARE AVAILABLE FOR ALL LOTS MANUFACTURED IN FRANKLIN, AS THE LOT NUMBER WAS NOT PROVIDED, RETAIN SAMPLES WERE NOT TESTED. A REVIEW OF ALL LOT STERILITY TESTING PERFORMED FOR PRODUCT RELEASED BETWEEN APRIL 2015 & MAY 2018 CONFIRMED THAT NO ORGANISM GROWTH WAS IDENTIFIED FOR ANY LOTS RELEASED DURING THE SHELF-LIFE OF THIS PRODUCT. CONCLUSION(S): THE ROOT CAUSE ANALYSIS OF THE REPORTED INFECTION CASES UNDER (B)(4) HAS NOT IDENTIFIED A DIRECT CAUSATION BETWEEN THE INFECTIONS AND THE BD FRANKLIN PRODUCT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 1

    TYPE OF REPORT: THE INITIAL MDR WAS SUBMITTED AS A 30-DAY REPORT. BD HAS CHANGED OUR POSITION ON THIS INCIDENT AND WE ARE MAKING A CORRECTION TO REPORT THE MDR AS A 5-DAY REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INFECTIONS ASSOCIATED WITH CENTRAL LINES AND THE USE OF A 5 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10 ML SYRINGE, 10 USP UNITS/ML WERE BEING INVESTIGATED BY THE FDA. THERE WAS NO EVIDENCE THAT THE BD DEVICE IS IMPLICATED BUT ALL SOURCES AND COMMON PRODUCTS ARE BEING INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312983 5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 USP UNITS/ML PREFILLED HEPARIN FLUSH SYRINGE FOZ BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903065104

    Patients

    Seq Age Sex Outcome Treatment
    1 Other