BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINC 12 FRENCH SUCTION CATHETER & SLEEVE

    MDR report key: 1329050 · Received February 26, 2009

    Report

    Report Number
    MW5010119
    Event Type
    Malfunction
    Date Received
    February 26, 2009
    Date of Event
    February 24, 2009
    Report Date
    February 26, 2009
    Manufacturer
    MEDLINE INDUSTRIES, INC
    Product Code
    BSY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    PARENT ATTEMPTED TO SUCTION PEDIATRIC PT AND WAS UNABLE TO SUCCESSFULLY PASS CATHETER THREE TRACH DUE TO SIZE. UPON EXAMINATION OF CATHETER, PARENT COMPARED DEVICE TO ANOTHER NEW CATHETER AND DISCOVERED TIP WAS MUCH LARGER THAN USUAL. 12 FRENCH AND THUMB PART WAS ALSO DIFFERENT COLOR. PT WAS NOT AFFECTED. PATIENT REPLACED CATHETER AND SUCTIONED PT AS USUAL. ALL SIMILAR CATHETERS WERE ISOLATED AND REPORTED TO RRT. ALL UNSENT STOCK CHECKED FOR AFFECTED LOT#. PARENTS/CAREGIVERS NOTIFIED OF DEFECT AND IS TO MAINTAIN CLOSELY. AFFECTED CATHETERS APPEAR TO BE INTERMINGLED WITH OTHER CATHETERS AND POSSIBLY SHIPPED IN THE MANNER. DETAILED MESSAGE LEFT WITH MANUFACTURERS REP WITH NO RETURN CALLS @ THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDLINC 12 FRENCH SUCTION CATHETER & SLEEVE 12 FR SUCTION CATHETER WITH SLEEVE BSY MEDLINE INDUSTRIES, INC 08LB4241
    2 MEDLINC 12 FRENCH SUCTION CATHETER & SLEEVE 12 FR SUCTION CATHETER WITH SLEEVE BSY MEDLINC INDUSTRIES, INC 08LB4241

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR