BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4060439 · Received September 4, 2014

    Report

    Report Number
    1416980-2014-29534
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 11, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K123868
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED PARTICULATE MATTER INSIDE THE TUBING AT THE INJECTION SITE CLOSEST TO THE MALE LUER CONNECTOR. THE TUBING WAS CUT OPEN FOR A CLOSER INSPECTION, AND THE PARTICULATE MATTER WAS DETERMINED TO BE EMBEDDED INSIDE THE TUBING WALL AND NOT LOOSE IN THE FLUID PATH. STEREOMICROSCOPIC EXAMINATION SHOWED THE PARTICLE TO BE DARK AMBER IN COLOR, IRREGULAR IN SHAPE, SOFT TO THE BLADE, AND APPROXIMATELY 3.3 MM IN SIZE. A SECTION OF THE PARTICLE WAS FURTHER ANALYZED BY ENERGY-DISPERSIVE X-RAY SPECTROSCOPY AND FOURIER TRANSFORM INFRARED SPECTROSCOPY. UPON CONCLUSION OF THE ANALYSIS, THE PARTICULATE MATTER WAS IDENTIFIED AS POLYVINYL CHLORIDE PLASTICIZED WITH BIS(2-ETHYLHEXYL) PHTHALATE, THE SAME MATERIAL AS THE TUBING. THE CAUSE OF THE CONDITION WAS UNKNOWN. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERLINK CONTINU-FLO SOLUTION SET HAD PARTICULATE MATTER IN THE TUBING, WHICH WAS DESCRIBED AS A ¿FLEA OR A GNAT.¿ THE FOREIGN OBJECT WAS NOTED TO HAVE BEEN LOCATED ¿ABOUT 6 INCHES FROM THE PATIENT END WHERE THE TUBING IS SPIKED.¿ THIS WAS IDENTIFIED PRIOR TO USE IN THE EMERGENCY DEPARTMENT, AFTER THE SET¿S OUTER PACKAGING HAD BEEN OPENED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542769 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE SR13G17012

    Patients

    Seq Age Sex Outcome Treatment
    1