BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 15031428 · Received July 15, 2022

    Report

    Report Number
    2210968-2022-05561
    Event Type
    Malfunction
    Date Received
    July 15, 2022
    Date of Event
    May 27, 2022
    Report Date
    July 15, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GBX
    PMA / PMN Number
    CL I EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: (B)(4). PRODUCT NOT RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT IS THE PRODUCT CODE AND LOT NUMBER OF THE FAULTY DRAIN? PRODUCT CODE (GBX) AND LOT NUMBER (DYNJWE1000) SEEM UNRECOGNIZABLE IN OUR RECORDS, CAN YOU PLEASE CONFIRM THE DAMAGE DRAIN WAS A BLAKE DRAIN BY JOHNSON AND JOHNSON? CAN YOU PLEASE CLARIFY IF THE DRAIN BROKE INTO TWO OR MORE PIECES? DID LEAKAGE OCCUR WHEN THE DRAIN SNAPPED OFF? WAS A NEW DRAIN NEEDED TO CORRECT THE SITUATION? IF YES, WAS THE NEW DRAIN PLACED SURGICALLY DURING A SECOND PROCEDURE? NO PRODUCT IS AVAILABLE FOR RETURN. THIS MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF A USER FACILITY MEDWATCH: (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT OPEN HEART SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. THE CONNECTION WHERE THE DRAIN MEETS THE TUBING SNAPPED OFF WHILE RN WAS EMPTYING CONTAINER. THE DEVICE IS NOT AVAILABLE FOR RETURN. NO REPORTED PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2671635 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown