BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ROUND DRAIN

    MDR report key: 21346233 · Received February 10, 2025

    Report

    Report Number
    1018233-2025-00757
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Date of Event
    January 22, 2025
    Report Date
    March 4, 2025
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    GBX
    UDI-DI
    00801741049460
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW, BD HAS DETERMINED THAT THIS MDR WAS REPORTED IN ERROR AS IT WAS FOUND TO BE A DUPLICATE OF AN EVENT PREVIOUSLY REPORTED. 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 THEY HAD AN END USER WHO HAD BEEN HAVING ISSUES WITH THE MFG# 0070310.THE NURSE WAS MILKING THE WOUND DRAIN AND THE TUBING SNAPPED IN THE MIDDLE WHERE THE NURSE WAS MILKING THAT. THAT HAD HAPPENED ON TWO OCCASIONS. PER CUSTOMER VIA PHONE ON 05FEB2025, IT WAS REPORTED THAT THE DEVICE HAD BEEN THROWN AWAY. THERE WAS NO IMPACT TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEY HAD AN END USER WHO HAD BEEN HAVING ISSUES WITH THE MFG#: 0070310. THE NURSE WAS MILKING THE WOUND DRAIN AND THE TUBING SNAPPED IN THE MIDDLE WHERE THE NURSE WAS MILKING THAT. THAT HAD HAPPENED ON TWO OCCASIONS. PER CUSTOMER VIA PHONE ON (B)(6) 2025, IT WAS REPORTED THAT THE DEVICE HAD BEEN THROWN AWAY. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1753153 SILICONE ROUND DRAIN WOUND DRAINAGE GBX C.R. BARD, INC. (COVINGTON) -1018233 NGJV3680 00801741049460

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other