BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE FLAT DRAIN

    MDR report key: 22849733 · Received August 20, 2025

    Report

    Report Number
    1018233-2025-06886
    Event Type
    Malfunction
    Date Received
    August 20, 2025
    Date of Event
    August 19, 2025
    Report Date
    February 17, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    GBX
    UDI-DI
    00801741090752
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED CAUSE UNKNOWN. RECEIVED 6 UNOPENED HUBLESS SILICONE FLAT DRAIN AND 2 IN OPENED PACKAGING. VERIFIED MATERIAL NUMBER 0070440 AND BATCH NUMBER NGKR3522. VISUAL INSPECTION NOTED THAT THERE WERE WHITE PARTICLES ON THE CLEAR TUBING. 5 OUT 6 UNOPENED HUBLESS SILICONE FLAT DRAINS HAD FOREIGN WHITE PARTICLE PRESENT FOREIGN WHITE MATERIAL PRESENT IN OPENED RETURNED SAMPLES. PRODUCT LABELING WAS REVIEWED FOR THIS INVESTIGATION. THE REPORTED EVENT IS ADDRESSED WITHIN THE LABELING. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. CORRECTION: D,H. 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 OR MANAGER REPORTED A QUALITY ISSUE WITH BARD WOUND DRAINS, SPECIFICALLY INVOLVING WHITE STICKY FOREIGN BODIES. DESCRIBED AS SILICONE SLIVER FOUND ON THE SILICONE TUBING. THESE PARTICLES WERE LOCATED IN VARIOUS PLACES AND MUST BE MANUALLY REMOVED, WHICH WAS BOTH DIFFICULT AND CONCERNING FROM A CLINICAL STANDPOINT. THE TEAM, INCLUDING SURGEONS, WAS UNCOMFORTABLE WITH ANYONE HANDLING THE TUBING ONCE IT WAS BEING INSERTED, DUE TO STERILITY AND SAFETY CONCERNS. PER NOTIFICATION FROM UCC ON 08DEC2025, IT WAS REPORTED THAT FOREIGN WHITE MATERIAL PRESENT IN OPENED RETURNED SAMPLES WAS FOUND DURING SAMPLE EVALUATION ON 15OCT2025.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OR MANAGER AT JUPITER OUTPATIENT SURGERY CENTER, REPORTED A QUALITY ISSUE WITH BARD WOUND DRAINS, SPECIFICALLY INVOLVING WHITE STICKY FOREIGN BODIES. DESCRIBED AS SILICONE SLIVER FOUND ON THE SILICONE TUBING. THESE PARTICLES WERE LOCATED IN VARIOUS PLACES AND MUST BE MANUALLY REMOVED, WHICH WAS BOTH DIFFICULT AND CONCERNING FROM A CLINICAL STANDPOINT. THE TEAM, INCLUDING SURGEONS, WAS UNCOMFORTABLE WITH ANYONE HANDLING THE TUBING ONCE IT WAS BEING INSERTED, DUE TO STERILITY AND SAFETY CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296680 SILICONE FLAT DRAIN WOUND DRAIN GBX C.R. BARD INC. (COVINGTON) -1018233 NGKR3522 00801741090752

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other