BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ROUND DRAIN

    MDR report key: 15833486 · Received November 21, 2022

    Report

    Report Number
    1018233-2022-08848
    Event Type
    Malfunction
    Date Received
    November 21, 2022
    Date of Event
    November 2, 2022
    Report Date
    March 17, 2023
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    GBX
    UDI-DI
    00801741049446
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO ¿ INCORRECT DIMENSIONS ". IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. A LABELING REVIEW IS NOT REQUIRED BECAUSE LABELING COULD NOT HAVE PREVENTED THE REPORTED ISSUE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SILICONE ROUND DRAIN (MAT CODE 113357) USED FOR A BREAST MASTECTOMY WAS REMOVED BY DOCTOR AND STATED THAT DRAIN WAS TOO ROUGH AND MIGHT CAUSE TRAUMA TO THE SURGICAL SITE UPON REMOVAL. ANOTHER SILICONE DRAIN WAS OPENED, CARDINAL BRAND (MAT CODE 30793), WHICH WAS SMOOTHER AND DID NOT HAVE THE ROUGH EDGES THAT WOULD TRAUMATIZE THE SURGICAL SITE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SILICONE ROUND DRAIN (MAT CODE 113357) USED FOR A BREAST MASTECTOMY WAS REMOVED BY DOCTOR AND STATED THAT DRAIN WAS TOO ROUGH AND MIGHT CAUSE TRAUMA TO THE SURGICAL SITE UPON REMOVAL. ANOTHER SILICONE DRAIN WAS OPENED, CARDINAL BRAND (MAT CODE 30793), WHICH WAS SMOOTHER AND DID NOT HAVE THE ROUGH EDGES THAT WOULD TRAUMATIZE THE SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365657 SILICONE ROUND DRAIN WOUND DRAIN GBX C.R. BARD, INC. (COVINGTON) -1018233 0070220 UNK 00801741049446

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other