BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE IRRIGATION BULK / CLEAN, 50ML

    MDR report key: 7046802 · Received November 20, 2017

    Report

    Report Number
    1018233-2017-06023
    Event Type
    Malfunction
    Date Received
    November 20, 2017
    Date of Event
    October 27, 2017
    Report Date
    December 4, 2017
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KYZ
    UDI-DI
    10801741051378
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: ¿IRRIGATION SYRINGE ¿ BULB TYPE, 50CC LATEX-FREE SINGLE USE ONLY. DO NOT RESTERILIZE. STERILE UNLESS PACKAGE IS OPENED OR DAMAGED. DO NOT USE IF PACKAGE IS OPENED OR DAMAGED. STERILIZED BY EO. AUTHORIZED REPRESENTATIVE MANUFACTURER USE BY. ATTENTION, SEE INSTRUCTIONS FOR USE. NOTE: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LAWS AND REGULATIONS.¿ (B)(4). THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LONG BLACK HAIR WITHIN THE ASEPTO SYRINGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LONG BLACK HAIR WITHIN THE ASEPTO SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826383 SYRINGE IRRIGATION BULK / CLEAN, 50ML SYRINGE KYZ C.R. BARD, INC. (COVINGTON) -1018233 NGBU1404 10801741051378

    Patients

    Seq Age Sex Outcome Treatment
    1