BEUDAMED
    FDA Adverse Event Death Summary report: N

    NURSE ASSIST

    MDR report key: 6214768 · Received December 29, 2016

    Report

    Report Number
    1650927-2016-00019
    Event Type
    Death
    Date Received
    December 29, 2016
    Date of Event
    December 21, 2016
    Report Date
    December 29, 2016
    Manufacturer
    NURSE ASSIST, INC.
    Product Code
    NGT
    UDI-DI
    0+B1501210BP0C
    PMA / PMN Number
    K150143
    Removal / Correction Number
    1650927-10/14/2016-001-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NURSE ASSIST SALINE FLUSH SYRINGES ARE SINGLE-USE DEVICES. THE COMPANY DOES NOT KNOW IF THE PRODUCTS WERE REPROCESSED OR REUSED ON PATIENTS. NO USED SYRINGES WERE RETURNED TO THE MANUFACTURER. MANUFACTURER TESTED RETAINED SAMPLES FOR BIOBURDEN, AND THERE WAS NO PRESENCE OF B. CEPACIA IN THOSE SAMPLES. STERILITY TESTING ON RETAINED SAMPLES CONFIRMED THAT THERE WAS NO GROWTH IN THE PRODUCT. ON (B)(6) 2016, THE (B)(4) DEPARTMENT OF HEALTH (PADOH) INFORMED NURSE ASSIST THAT SYRINGES FROM LOT NUMBER 1607418 TESTED POSITIVE FOR B. CEPACIA. PADOH SENT THE MANUFACTURER UNUSED SYRINGES FROM ONE OF THE AFFECTED FACILITIES FOR TESTING. THE TESTING CONFIRMED THAT THE SYRINGES DISTRIBUTED BY PHARMSCRIPT, LLC (LOT #: 1607418) CONTAIN BURKHOLDERIA MULTIVORANS (A SUB SPECIES OF THE BURKHOLDERIA CEPACIA COMPLEX). LOT # 1607418 WAS NOT DISTRIBUTED TO ANY OTHER CUSTOMERS BY THE MANUFACTURER. (B)(4). NURSE ASSIST INITIATED A VOLUNTARY RECALL FOR ALL LOTS OF SALINE FLUSH SYRINGES. THE REMOVAL WAS INITIATED ON (B)(6) 2016. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE CENTERS FOR DISEASE CONTROL (CDC) WEBSITE NOTED 3 ADDITIONAL INFECTION CASES (YIELDING B. CEPACIA IN A PATIENT WHO BETWEEN (B)(6) 2016 AND THE PRESENT ((B)(6) 2016) RECEIVED INTRAVENOUS CARE AT A FACILITY THAT WAS UTILIZING PREFILLED 0.9% SODIUM CHLORIDE IV FLUSH SOLUTION MANUFACTURED BY NURSE ASSIST) AND ONE ADDITIONAL DEATH ASSOCIATED WITH THE B. CEPACIA INFECTIONS PREVIOUSLY REPORTED BY NURSE ASSIST (SEE MDR REPORTS: 1650927-2016-00001 THROUGH 1650927-2016-00018). ACCORDING TO THE CDC, IT IS NOT KNOWN WHETHER THE DEATH WAS THE RESULT OF THE INFECTION OR OF ANOTHER UNDERLYING CAUSE. DESPITE EFFORTS, MANUFACTURER HAS BEEN UNABLE TO OBTAIN FURTHER INFORMATION ABOUT THE REPORTED EVENTS. BECAUSE OF THIS, AND BASED ON GUIDANCE FROM THE FDA, NURSE ASSIST IS TREATING THESE REPORTS AS A LITERATURE SOURCE. NO INFORMATION IS KNOWN ABOUT THE SPECIFIC CASES OR PATIENTS, THUS A SINGLE MDR REPORT WILL BE FILED FOR EACH CDC REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862278 NURSE ASSIST NORMAL SALINE FLUSH SYRINGE NGT NURSE ASSIST, INC. 1210-BP 1607418 0+B1501210BP0C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other