BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ROUND DRAIN

    MDR report key: 22666904 · Received July 30, 2025

    Report

    Report Number
    1018233-2025-06303
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    July 28, 2025
    Report Date
    October 3, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    GBX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. INSTRUCTIONS FOR USE WERE REVIEWED FOR THIS INVESTIGATION. THE LABELING IS FOUND TO BE ADEQUATE. THE DHR REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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 INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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 CALLER STATED THAT THE WOUND DRAIN ((B)(6) DID NOT FIT ON THE SILICONE EVACUATOR BULB (B)(6) AND THE OPERATING ROOM STAFF HAD TO DILATE THE DRAIN FOR THE EVACUATOR TO FIT. PLEASE SEE THE ATTACHED BROCHURE. THE (B)(6) SILICONE DRAIN WAS SUPPOSED TO FIT (B)(6) SILICONE BULB EVACUATOR WITHOUT AN ADAPTER. THE PRODUCTS CONNECTED USING FRICTION. BD DID NOT ADVISE ALTERING THE DRAIN OR EVACUATOR AS THAT COULD COMPROMISE THE INTEGRITY OF THE PRODUCT. THAT INQUIRY WOULD BE REPORTED TO BD PRODUCT COMPLAINTS FOR INVESTIGATION

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CALLER STATED THAT THE WOUND DRAIN (0070220) DID NOT FIT ON THE SILICONE EVACUATOR BULB (0070740) AND THE OPERATING ROOM STAFF HAD TO DILATE THE DRAIN FOR THE EVACUATOR TO FIT. THE 0070220 SILICONE DRAIN WAS SUPPOSED TO FIT 0070740 SILICONE BULB EVACUATOR WITHOUT AN ADAPTER. THE PRODUCTS CONNECTED USING FRICTION. BD DID NOT ADVISE ALTERING THE DRAIN OR EVACUATOR AS THAT COULD COMPROMISE THE INTEGRITY OF THE PRODUCT. THAT INQUIRY WOULD BE REPORTED TO BD PRODUCT COMPLAINTS FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514956 SILICONE ROUND DRAIN SILICONE ROUND DRAIN GBX C.R. BARD INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other