BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALL PURPOSE DRAINAGE CATHETER

    MDR report key: 2273629 · Received September 27, 2011

    Report

    Report Number
    1036710-2011-00011
    Event Type
    Other
    Date Received
    September 27, 2011
    Date of Event
    August 29, 2011
    Report Date
    August 29, 2011
    Manufacturer
    ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES
    Product Code
    GBQ
    PMA / PMN Number
    E544937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE RECEIVED A REPORT FROM OUR DISTRIBUTOR IN (B)(4), WHICH STATES DURING THEIR INCOMING INSPECTION THEY FOUND THE POUCH WAS DRILLED. THE LOT NUMBER REPORTED WAS PACKAGED IN 2008. A SALES REPORT WAS RUN FOR THE REPORTED LOT NUMBER AND IT WAS FOUND THE PRODUCT WAS SENT TO THE CUSTOMER IN 2008. DESPITE CONTINUOUS EFFORTS, WE HAVE NOT RECEIVED THE PRODUCT, NOR PICTURES OF THE POUCH.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT THE PACKAGING WAS COMPROMISED ON TWO PACKAGES OF SKATER DRAINAGE CATHETERS. THESE DEVICES WERE NOT USED ON PTS, HOWEVER, POTENTIAL FOR INJURY EXISTS IF A NON STERILE DEVICE IS USED ON A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALL PURPOSE DRAINAGE CATHETER SKATER ALL PURPOSE DRAINAGE CATHETER GBQ ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES 756512025 82901QDS

    Patients

    Seq Age Sex Outcome Treatment
    1