BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAY SKIN PREP PVP-1 SCRUB CARE

    MDR report key: 2413463 · Received January 12, 2012

    Report

    Report Number
    8030673-2012-00073
    Event Type
    Malfunction
    Date Received
    January 12, 2012
    Date of Event
    May 26, 2011
    Report Date
    January 12, 2012
    Manufacturer
    CAREFUSION
    Product Code
    OJU
    PMA / PMN Number
    K781797
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A RETROSPECTIVE REVIEW OF ALL COMPLAINTS DURING THIS TIMEFRAME WAS CONDUCTED BY THE NEW CAREFUSION (B)(4) TEAM IN ACCORDANCE WITH INTERNAL STANDARD OPERATING PROCEDURES AND IT WAS DETERMINED THAT THIS EVENT NECESSITATES SUBMISSION AS A MEDICAL DEVICE REPORTABLE (MDR) IN ACCORDANCE WITH 21 CODE OF FEDERAL REGULATION (CFR) PART 803.

    Description of Event or Problem · 1

    INCIDENT OCCURED ON (B)(6) 2011. WAS INFORMED ON (B)(4) 2011 WAS REPORTED WITHIN 24 HOURS. DR. PREPPED VAGINAL VAULT AREA OF PATIENT WITH FOAM SPONGE STICK AND FOAM PORTION CAME OFF STICK INSIDE OF THE PATIENT. DR. HAD TO RETRIEVE FOAM PIECE FROM INSIDE OF PATIENT. NO SAMPLE WAS PROVIDED BY THE CUSTOMER; THEREFORE AN EVALUATION OF THE COMPLAINT DEVICE FOR DEFICIENCY OF CONSTRUCTION COULD NOT BE PERFORMED. HOWEVER SAMPLES OF OUR CURRENT PRODUCTION PROCESS WERE REVIEWED AND NO PROBLEMS RELATED WITH THIS ISSUE WERE OBSERVED. HOWEVER IN SIMILAR COMPLAINT THIS INCIDENT WAS IDENTIFIED THE CONTOUR STICK SPONGES WERE WITHOUT SEAL. THEREFORE TO CONFIRM THE ISSUE REPORTED ON THIS COMPLAINT IS NECESSARY THE SAMPLE OR PICTURE. THE DEVICE HISTORY RECORDS FOR THE LOT REPORTED WERE EVALUATED FOR ANY ISSUES RELATED WITH THIS CUSTOMER REPORT. THE PRODUCT WAS MANUFACTURED, INSPECTED AND RELEASED IN ACCORDANCE WITH OUR INTERNAL PROCEDURES AND NO ISSUES WERE OBSERVED. OUR MANUFACTURING PROCESS WAS REVIEWED AND WE COULDN'T FIND ANYTHING THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. (B)(4). IN ADDITION THE PRE-ASSEMBLY CONTOUR STICK SPONGES (UNSEALED) ARE (B)(4). AN INTERNAL INVESTIGATION (B)(4) WAS INITIATED IN ORDER TO DETERMINE THE ROOT CAUSE FOR THIS KIND OF REPORT. AT THIS TIME IS NOT POSSIBLE TO DETERMINE THE CORRECTIVE ACTIONS FOR THIS ISSUE REPORTED. HOWEVER AN INTERNAL INVESTIGATION (B)(4) WAS INITIATED IN ORDER TO DETERMINE THE CORRECTIVE ACTIONS FOR THIS KIND OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAY SKIN PREP PVP-1 SCRUB CARE APPLICATOR, ABSORBENT TIPPED, STERILE OJU CAREFUSION 4468 Y10N2147

    Patients

    Seq Age Sex Outcome Treatment
    1