BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE FLAT DRAIN

    MDR report key: 23110213 · Received September 22, 2025

    Report

    Report Number
    1018233-2025-08423
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    September 18, 2025
    Report Date
    December 19, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    GBX
    UDI-DI
    00801741090745
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 REPORTED EVENT IS ADDRESSED WITHIN THE LABELING AS IT STATES, "CAUTION: TO AVOID THE POSSIBILITY OF DRAIN DAMAGE OR BREAKAGE: ADDITIONAL PERFORATIONS SHOULD NOT BE MADE IN THE DRAINS. AVOID SUTURING THROUGH DRAINS. DRAINS SHOULD LIE FLAT AND IN LINE WITH THE SKIN EXIT AREAS. PARTICULAR CARE SHOULD BE TAKEN TO AVOID ANY OBSTACLES TO THE DRAIN EXIT PATH. DRAINS SHOULD BE CHECKED DURING CLOSURE FOR FREE MOTION TO AVOID POSSIBILITY OF BREAKAGE. DRAIN REMOVAL SHOULD BE DONE GENTLY BY HAND. THEY SHOULD NOT BE HANDLED WITH POINTED, TOOTHED OR SHARP INSTRUMENTS WHICH COULD CAUSE CUTS OR NICKS AND LEAD TO SUBSEQUENT STRUCTURAL FAILURE OF THE DRAIN." A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. INITIAL REPORTER NAME: (B)(6) HOSPITAL. 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. INITIAL REPORTER NAME: (B)(6). 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 THE FOUR NEURO SURGERY CASES AT (B)(6) HOSPITAL HAVE EXPERIENCED COMPLICATIONS DUE TO ISSUES WITH THE 10 MM FLAT DRAIN (PRODUCT CODE: 0070370). THE TUBING IS REPORTEDLY FLIMSY AND PRONE TO CRIMPING, WHICH INTERFERES WITH PROPER INSERTION. IN ONE INSTANCE, THE SURGEON WAS UNABLE TO FULLY PLACE THE DRAIN, RAISING SAFETY CONCERNS. AS A RESULT, FOUR PATIENTS REQUIRED RETURN TRIPS TO THE OR, AND ONE DEVELOPED A HEMATOMA. THE ISSUE APPEARS TO BE LINKED TO A PRODUCT CHANGE THAT OCCURRED OVER THE SUMMER, AND THE HOSPITAL IS CURRENTLY WORKING WITH EMR STAFF TO RETRIEVE THE AFFECTED LOT NUMBERS. FOR FURTHER INVESTIGATION AND RESOLUTION, SAMPLES SHOULD BE SENT TO: PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 05NOV2025, IT WAS REPORTED THAT THE CUSTOMER WAS NOT AWARE OF SPECIFIC HARM, ALL 4 CASES, THAT WERE BROUGHT TO THEIR ATTENTION, HAD THEIR DRAINS DISCONTINUED EARLIER THAN DESIRED. NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FOUR NEURO SURGERY CASES AT (B)(6) HOSPITAL HAVE EXPERIENCED COMPLICATIONS DUE TO ISSUES WITH THE 10 MM FLAT DRAIN (PRODUCT CODE: 0070370). THE TUBING IS REPORTEDLY FLIMSY AND PRONE TO CRIMPING, WHICH INTERFERES WITH PROPER INSERTION. IN ONE INSTANCE, THE SURGEON WAS UNABLE TO FULLY PLACE THE DRAIN, RAISING SAFETY CONCERNS. AS A RESULT, FOUR PATIENTS REQUIRED RETURN TRIPS TO THE OPERATING ROOM, AND ONE DEVELOPED A HEMATOMA. THE ISSUE APPEARS TO BE LINKED TO A PRODUCT CHANGE THAT OCCURRED OVER THE SUMMER, AND THE HOSPITAL IS CURRENTLY WORKING WITH EMR STAFF TO RETRIEVE THE AFFECTED LOT NUMBERS. FOR FURTHER INVESTIGATION AND RESOLUTION, SAMPLES SHOULD BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2654394 SILICONE FLAT DRAIN WOUND DRAIN GBX C.R. BARD INC. (COVINGTON) -1018233 UNK 00801741090745

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention