BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2903405 · Received January 9, 2013

    Report

    Report Number
    1416980-2013-00578
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 17, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SEPARATION OR DETACHMENT OCCURRED BELOW THE Y-INJECTION PORT. THE CONDITION WAS DISCOVERED PRIOR TO THE CHEMO DRUG BEING ATTACHED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. NO SAMPLE WAS RETURNED, PRECLUDING FURTHER EVALUATION. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE FOR EVALUATION, THEREFORE THE REPORTED CONDITION COULD NOT BE CONFIRMED OR DUPLICATED AND AN ASSIGNABLE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510(K) NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4).EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED FOR EVALUATION. UPON VISUAL INSPECTION THE TUBING WAS FOUND TO BE SEPARATED FROM THE Y-SITE. AN APPROPRIATE SOLVENT MARK WAS OBSERVED AT THE TUBING END AND NO SIGN OF TUBING TWISTED FOUND ON THE SAMPLE. THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE FACILITY CONTACTED BAXTER (B)(4) TO REPORT A Y-TYPE BLOOD/SOLUTION INTERLINK SET THAT THE "DISTAL SEGMENT OF THE LINE BECAME DETACHED WHILE IN USE". THE "FLUID INFUSING WAS NORMAL SALINE. THE LINE IS WET WITH NORMAL SALINE. LEAKING OF CYTOTOXIC CHEMICAL". THE MALFUNCTION WAS OBSERVED TO HAVE OCCURRED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT; THERE WAS NOT REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12188 ACCESS SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE - SINGAPORE SR12F04054

    Patients

    Seq Age Sex Outcome Treatment
    1