BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4844907 · Received June 15, 2015

    Report

    Report Number
    1416980-2015-25265
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Date of Event
    December 6, 2014
    Report Date
    May 21, 2015
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FMG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER STATED THAT THE DEVICE IS FROM ONE OF THE THREE LOT NUMBERS: 14G01V195, 14E27V614, OR 14E01V554. LOT 14G01V195 WAS MANUFACTURED ON JULY 10, 2014, LOT 14E27V614 WAS MANUFACTURED ON JUNE 2, 2014, LOT 14E01V554 WAS MANUFACTURED ON MAY 22, 2014. THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED A CRACK ON THE FRAME OF THE STOPCOCK. A LEAK TEST WAS PERFORMED AND A LEAK WAS OBSERVED AT THE LOCATION OF THE CRACK. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED FOR EACH LOT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STOPCOCK HAD A LEAK. THE STOPCOCK WAS PLACED ON THE LEFT FEMORAL OF THE PATIENT AND APPEARED LIKE IT HAD HOLES OR CRACKS. THERE WAS BLEEDING OBSERVED IN THE PATIENT¿S BED HOWEVER THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389664 ACCESS STOPCOCK, I.V. SET FMG BAXTER HEALTHCARE - MALTA

    Patients

    Seq Age Sex Outcome Treatment
    1