BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERCUNAV MP008R-B BUTTON PROBE

    MDR report key: 1880496 · Received October 13, 2010

    Report

    Report Number
    3006377159-2010-00001
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    JAK
    PMA / PMN Number
    K053610
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS DISCOVERED INTERNALLY. NO PT OR USER INJURY HAS BEEN REPORTED. CORRECTIVE ACTION AND IMPACT ON DISTRIBUTED PRODUCT IS CURRENTLY BEING EVALUATED. ADD'L LOT/EXP NUMBERS: C151005, 03/31/2013; E111003, 05/31/2013; E251002, 05/31/2013.

    Description of Event or Problem · 1

    AN ISSUE WAS DISCOVERED INTERNALLY RELATING TO THE PACKAGING OF THE MP008R-B BUTTON PROBE. THE PROTECTIVE TUBING HAD COME OFF OF THE METAL PROBE TIP WITHIN THE SEALED POUCH. THE PROTECTIVE TUBING IS REQUIRED TO PROTECT THE STERILE TYVEK POUCH FROM BEING PUNCTURED BY THE POINTED, METAL TIP. SHOULD THE METAL TIP PUNCTURE THE PACKAGING, OR THE POUCH SEAL BECOME COMPROMISED, THEN THE STERILITY OF THE BUTTON PROBE IS ALSO COMPROMISED. NO INJURY HAS OCCURRED AND THERE IS NO PT INVOLVEMENT WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUNAV MP008R-B BUTTON PROBE COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK PHILIPS HEALTHCARE MP008R-B I280903

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other