BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WOLF-PAK NORMAL SALINE IV 10ML FILL IN 12ML FLUSH SYRINGE

    MDR report key: 5867403 · Received August 10, 2016

    Report

    Report Number
    1000151124-2016-00004
    Event Type
    Malfunction
    Date Received
    August 10, 2016
    Date of Event
    January 19, 2016
    Report Date
    August 9, 2016
    Manufacturer
    WOLF MEDICAL SUPPLY
    Product Code
    NGT
    PMA / PMN Number
    K111034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL INFORMATION ABOUT THIS EVENT WAS PROVIDED TO AQUABILITI BY THE PRIVATE LABEL MANUFACTURER, WOLF MEDICAL SUPPLY (WMS). THE INFORMATION STATED THEIR (WMS) CUSTOMER ENCOUNTERED A SYRINGE WITH A "RUSTY" COLOR. AQUABILITI ISSUED A RETURN MATERIAL AUTHORIZATION. THE DEVICE EXHIBITING THE "RUSTY" COLOR WAS RECEIVED AND FORWARDED TO THE SYRINGE MANUFACTURER FOR EVALUATION. THE SYRINGE MANUFACTURED STATED THE REPORTED CONDITION ("RUSTY" COLOR SOLUTION) WAS OBSERVED. A METAL CONTAMINANT WAS FOUND IN THE SHOULDER OF THE SYRINGE. THE CONTAMINANT WAS SENT TO A LABORATORY FOR COMPOSITION ANALYSIS. THE RESULTS SHOWED THE CONTAMINANT WAS A MIXTURE OF IRON, CHROMIUM, ALUMINUM, MANGANESE, NICKEL, AND ZINC. THE SYRINGE MANUFACTURER RESPONDED TO US THE SOURCE OF CONTAMINANT WAS TRACED BACK TO THREE POTENTIAL DEFICIENCES AT THEIR MANUFACTURING FACILITY. CLEANING METHODS MAY BE INSUFFICIENTLY ESTABLISHED OR MAY NOT HAVE BEEN PROPERLY FOLLOWED, RAW MATERIALS USED IN THE CONSTRUCTION OF THE SYRINGE PLUNGER TIP MAY HAVE BEEN CONTAMINATED, OR POSSIBLE PRODUCTION EQUIPMENT WEAR MAY BE GENERATING METALS THAT CONTAMINATE THE MANUFACTURING PROCESS. THE SYRINGE MANUFACTURER OPENED A FORMAL CORRECTIVE ACTION FOR THIS ISSUE, AND THEIR MANUFACTURING AND QUALITY ASSURANCE PERSONNEL HAVE BEEN MADE AWARE OF THIS COMPLAINT IN AN EFFORT TO FOCUS ATTENTION ON PREVENTING THIS ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER OF WOLF MEDICAL SUPPLY, INC. ENCOUNTERED A SYRINGE WITH A "RUSTY" COLOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517569 WOLF-PAK NORMAL SALINE IV 10ML FILL IN 12ML FLUSH SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT WOLF MEDICAL SUPPLY PS1012 KH04240

    Patients

    Seq Age Sex Outcome Treatment
    1 Other