BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WOUND DRAINAGE

    MDR report key: 20913574 · Received December 12, 2024

    Report

    Report Number
    1018233-2024-07939
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    November 19, 2024
    Report Date
    February 12, 2025
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    GCY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 BD.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME SINCE ROOT CAUSE WAS NOT IDENTIFIED. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. THE PRODUCT CATALOG NUMBER AND THE LOT NUMBER FOR THIS DEVICE ARE UNKNOWN. THEREFORE, BD IS UNABLE TO DETERMINE THE ASSOCIATED LABELING TO REVIEW. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ADAPTER WHICH CAME INSIDE THE 15F ROUND BARD DRAIN (L#2221069) DID NOT FIT ON THE NEW BD BULB RESERVOIRS (L# 2014696). THE CUSTOMER STATED THAT THE ADAPTER WAS IMPORTANT TO OBTAINING A GOOD SEAL, AND IT WAS CRUCIAL THAT THE ADAPTER BE COMPATIBLE WITH THE BULB RESERVOIR. IT LOOKED LIKE THEY NEEDED TO GO BACK TO THE ETHICON BLAKE DRAINS WE WERE USING BEFORE THE CONVERSION (L# 36306). THE 19F BARD DRAIN (L# 2221070) INCLUDES TWO ADAPTERS, ONE OF WHICH FITS THE RESERVOIR SO THAT DRAIN WOULD BE OKAY FOR OUR CONTINUED USE. ESSENTIALLY, THE 15F ROUND BARD DRAIN (BD# 07229) DOES NOT CREATE A TIGHT SEAL WITH THE BULB (BD#0070740) AS THE ADAPTER WAS NOT COMPATIBLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ADAPTER WHICH CAME INSIDE THE 15F ROUND BARD DRAIN (L#: 2221069) DID NOT FIT ON THE NEW BD BULB RESERVOIRS (L#: 2014696). THE CUSTOMER STATED THAT THE ADAPTER WAS IMPORTANT TO OBTAINING A GOOD SEAL, AND IT WAS CRUCIAL THAT THE ADAPTER BE COMPATIBLE WITH THE BULB RESERVOIR. IT LOOKED LIKE THEY NEEDED TO GO BACK TO THE ETHICON BLAKE DRAINS WE WERE USING BEFORE THE CONVERSION (L#: 36306). THE 19F BARD DRAIN (L#: 2221070) INCLUDES TWO ADAPTERS, ONE OF WHICH FITS THE RESERVOIR SO THAT DRAIN WOULD BE OKAY FOR OUR CONTINUED USE. ESSENTIALLY, THE 15F ROUND BARD DRAIN (BD#: 07229) DOES NOT CREATE A TIGHT SEAL WITH THE BULB (BD#: 0070740) AS THE ADAPTER WAS NOT COMPATIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2155262 WOUND DRAINAGE WOUND DRAINAGE GCY C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other