BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUASTAT 10ML/12ML SINGLE DOSE FLUSH SYRINGE

    MDR report key: 6176306 · Received December 15, 2016

    Report

    Report Number
    1000151124-2016-00006
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    December 3, 2016
    Report Date
    December 14, 2016
    Manufacturer
    AQUABILITI
    Product Code
    NGT
    UDI-DI
    00859809005026
    PMA / PMN Number
    K111034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER COMPLETING THE FLUSH, THE CLINICIAN PROCEEDED TO REMOVE THE SYRINGE FROM THE ARTERIAL LIMB HUB OF A CENTRAL VENOUS CATHETER AND THE LUER FROM ONE OF AQUABILITI'S SYRINGE BROKE OFF AND REMAINED IN THE HUB. THE PATIENT HAD TO BE TRANSPORTED TO THE HOSPITAL FROM (B)(6) CLINIC TO THE RADIOLOGY INTERVENTION LAB AT THE HOSPITAL (NAME OF FACILITY IS UNKNOWN) FOR REPAIR OF THE HUB. MS. (B)(6) STATED THE CATHETER DID NOT HAVE TO BE REPLACED. MS. (B)(6) AGREED TO SEND THE REJECTED SYRINGE BACK TO AQUABILITI FOR EVALUATION IF HER CORPORATE OFFICE ADVISED HER TO COMPLY. ATTEMPTS TO REACH HER BY PHONE ON 08-DEC-2016 @14:23 AND 09-DEC-2016 @ 12:53 WERE NOT SUCCESSFUL IN GETTING CONFIRMATION ON THE RETURN OF THE DEFECTIVE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826381 AQUASTAT 10ML/12ML SINGLE DOSE FLUSH SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT AQUABILITI 2T0806 KH04327 00859809005026

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention