BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 4053058 · Received September 2, 2014

    Report

    Report Number
    1416980-2014-29301
    Event Type
    Malfunction
    Date Received
    September 2, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 8, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    LHI
    PMA / PMN Number
    K973654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS LOT WAS MANUFACTURED MAY 9TH, 2014 - MAY 13TH, 2014. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION CONNECTED TO A PORT OF AN EMPTY SOLUTION BAG AND A DRUG VIAL. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. SIMULATED USE TESTING WAS PERFORMED BY DOCKING THE DEVICE TO AN IN-HOUSE SOLUTION BAG AND THE RETURNED DRUG VIAL. ACTIVATION AND MIXING WERE PERFORMED WITH NO ISSUES OR LEAKS NOTED. THE DEVICE WAS FOUND TO OPERATE PER SPECIFICATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED WITH THE VIAL-MATE; HOWEVER, THE DEVICE WAS DOCKED TO THE INCORRECT PORT ON THE SOLUTION BAG. THE REPORTED CONDITION WAS UNABLE TO BE REPLICATED; HOWEVER, CONNECTION OF THE VIAL-MATE TO AN INCORRECT PORT ON THE BAG WAS DISCOVERED AND IS A KNOWN CAUSE OF LEAKAGE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VIAL-MATE RECONSTITUTION DEVICE LEAKED FROM ¿AROUND THE BLUE PIECE OF THE ADAPTER¿, AT THE INTERFACE WITH A VIAFLEX CONTAINER (BAXTER PRODUCT). THIS OCCURRED AS A NURSE WAS PERFORMING RECONSTITUTION WITH 3.375 G OF A NON-BAXTER DRUG AND BEFORE PATIENT CONNECTION. THIS OCCURRED IMMEDIATELY AFTER ADMIXTURE. THE REPORTER STATED THAT THE VIAL-MATE WAS SECURELY ATTACHED TO BOTH THE BAG AND VIAL. THE NEEDLE WAS VISIBLY PENETRATING THE STOPPER AND THE VIAL-MATE WAS FULLY ACTIVATED. NO IRREGULARITIES WERE NOTICED WITH THE VIAL-MATE OR ITS PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534591 IVT DISPOSABLE SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE - CLEVELAND GR14D30029

    Patients

    Seq Age Sex Outcome Treatment
    1