BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE CHANNEL DRAIN WITHOUT TROCAR, 19 FR., ROUND HUBLESS, FULL FLUTED

    MDR report key: 6679850 · Received June 29, 2017

    Report

    Report Number
    1018233-2017-03405
    Event Type
    Malfunction
    Date Received
    June 29, 2017
    Report Date
    July 12, 2017
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
    Product Code
    GBX
    UDI-DI
    00801741051616
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: " DRAIN PLACEMENT AND THE FR SIZE IS INDICATED: REORDER #: DRAIN SIZE: DRAIN SHAPE: FLUTING TROCAR DEPTH INDICATOR: V072230, 19 FR. ROUND HUBLESS, FULL ¿, DOT. V072234, 24 FR. ROUND HUBLESS FULL ¿ DOT." (B)(4). THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SIZE OF THE CHANNEL DRAIN WAS LARGER THAN DEVICES PREVIOUSLY USED (B)(4), AND WOULD NOT FIT ON THE BULB. THE USER STATED THERE WAS A VISIBLE DIFFERENCE IN DIAMETER WHEN THE DRAINS WERE NEXT TO EACH OTHER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SIZE OF THE CHANNEL DRAIN WAS LARGER THAN DEVICES PREVIOUSLY USED (072230), AND WOULD NOT FIT ON THE BULB. THE USER STATED THERE IS A VISIBLE DIFFERENCE IN DIAMETER WHEN THE DRAINS ARE NEXT TO EACH OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459945 SILICONE CHANNEL DRAIN WITHOUT TROCAR, 19 FR., ROUND HUBLESS, FULL FLUTED CHANNEL DRAIN GBX PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 UNK 00801741051616

    Patients

    Seq Age Sex Outcome Treatment
    1