BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NURSE ASSIST

    MDR report key: 6138144 · Received December 1, 2016

    Report

    Report Number
    1650927-2016-00010
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    September 28, 2016
    Report Date
    October 28, 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. ON (B)(6) 2016, THE (B)(6) INFORMED NURSE ASSIST THAT SYRINGES FROM LOT NUMBER 1607418 TESTED POSITIVE FOR B. CEPACIA. (B)(6) SENT THE COMPANY UNUSED SYRINGES FROM ONE OF THE AFFECTED FACILITIES, AND TESTING ON THOSE PRODUCTS IS ON-GOING. MANUFACTURER IS ALSO AWARE THAT (B)(6) STATE DEPARTMENT OF HEALTH, (B)(6), AND (B)(6) DEPARTMENT OF HEALTH AND MENTAL HYGIENE HAVE ISSUED NOTICES REGARDING CASES OF B. CEPACIA INFECTION THAT MAY BE ASSOCIATED WITH NURSE ASSIST SALINE FLUSH SYRINGES, AND INVESTIGATIONS ARE STILL ON-GOING. NURSE ASSIST INITIATED A VOLUNTARY RECALL FOR ALL LOTS OF SALINE FLUSH SYRINGES. THE REMOVAL WAS INITIATED ON 10/04/2016. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2016, (B)(6) (A DISTRIBUTOR) VERBALLY REPORTED TO NURSE ASSIST THAT, BETWEEN (B)(6) 2016 AND (B)(6) 2016, 11 PATIENTS HAD EXPERIENCED INFECTIONS THAT WERE POTENTIALLY RELATED TO NURSE ASSIST'S SALINE FLUSH SYRINGES. THE FACILITIES BEGAN USING P/N 1210-BP ON (B)(6) 2016. (B)(6) NOTED THAT THERE WAS NO DIRECT EVIDENCE THAT THE SYRINGES ARE A ROOT CAUSE, BUT THAT THEY ARE COMMON TO THE PATIENTS WITH THE INFECTIONS. DESPITE EFFORTS, MANUFACTURER HAS BEEN UNABLE TO OBTAIN FURTHER INFORMATION ABOUT THE REPORTED EVENTS FROM (B)(6). ACCORDINGLY, THE 3500A FORM FOR EACH OF THE 11 REPORTED INFECTIONS WILL CONTAIN THE SAME INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789799 NURSE ASSIST NORMAL SALINE FLUSH SYRINGE NGT NURSE ASSIST, INC. 1210-BP 1607418 0+B1501210BP0C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other