BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6592972 · Received May 25, 2017

    Report

    Report Number
    1018233-2017-02683
    Event Type
    Malfunction
    Date Received
    May 25, 2017
    Report Date
    July 13, 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 Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE (IT WAS REPORTED THAT THE PACKAGING WAS LABELED FOR A 19FR DEVICE; BUT THE SIZE OF THE DEVICE WAS BIGGER THAN 19FR) WAS CONFIRMED. THE SAMPLE WAS RETURNED AND VISUALLY INSPECTED, AND NOTED NO OBVIOUS DEFECTS. PER DIMENSIONAL EVALUATION THE SAMPLE WAS MEASURED WITH FRENCH SCALE AND OPTICAL COMPARATOR. THE SAMPLE WAS CONFIRMED TO CORRESPOND WITH ONE PIECE 24FR CHANNEL DRAIN. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: ¿DRAIN PLACEMENT AND THE FR SIZE IS INDICATED: REORDER #V072230 19 FR., DRAIN SIZE: ROUND HUBLESS; DRAIN SHAPE: FULL ¿; FLUTING: DOT; TROCAR DEPTH INDICATOR. V072234 24 FR., ROUND HUBLESS, FULL ¿, DOT." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGING WAS LABELED AS A 19FR. DEVICE; HOWEVER, THE DEVICE INSIDE WAS ALLEGEDLY LARGER THAN 19FR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGING WAS LABELED AS A 19FR. DEVICE; HOWEVER, THE DEVICE INSIDE WAS ALLEGEDLY LARGER THAN 19FR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373421 SILICONE CHANNEL DRAIN WITHOUT TROCAR, 19 FR., ROUND HUBLESS, FULL FLUTED 19FR SILICONE CHANNEL DRAIN GBX PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 NGAZ3014 00801741051616

    Patients

    Seq Age Sex Outcome Treatment
    1