BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAKE (R) DRAIN 10FR ROUND

    MDR report key: 11406248 · Received March 3, 2021

    Report

    Report Number
    2210968-2021-01937
    Event Type
    Malfunction
    Date Received
    March 3, 2021
    Date of Event
    February 10, 2021
    Report Date
    February 17, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GBX
    UDI-DI
    10705031003552
    PMA / PMN Number
    CL I EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 6/8/2021. H3 EVALUATION: COMPLAINT SAMPLE WAS RECEIVED. AFTER OPENING THE COMPLAINT SAMPLE PRIMARY PACK, IT WAS OBSERVED THAT THERE WAS A SMALL PIECE OF DRAIN. THE COMPLAINT SAMPLE (DRAIN) WAS NOT IN ORIGINAL ITS LENGTH. THE ACTUAL LENGTH OF DRAIN IS 1200MM HOWEVER, THE SIZE OF COMPLAINT DRAIN WAS 300MM. THE COMPLAINT SAMPLE PHOTOGRAPH WAS RECEIVED FOR ANALYSIS BUT ON THE BASIS OF PHOTOGRAPH IT CAN NOT BE CORELATE THE LEAKAGE DUE TO MANUFACTURING PROCESS. EVALUATION OF RETAIN SAMPLE WAS NOT DONE AS THE LOT NUMBER IS NOT SPECIFIED. 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. PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 6/8/2021. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED AND OBTAINED. TO DATE THE DEVICE HAS NOT BEEN RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. NO FURTHER INFORMATION IS AVAILABLE. WHAT IS THE LOT NUMBER? NO FURTHER INFORMATION IS AVAILABLE. WAS ANOTHER DRAIN NEEDED TO CORRECT THE SITUATION? NO FURTHER INFORMATION IS AVAILABLE. IF YES, WAS THE NEW DRAIN PLACED SURGICALLY DURING A SECOND PROCEDURE? DEVICE RETURN STATUS. WE REGULARLY CONTACT WITH SALES REP ABOUT THE DEVICE RETURNING. 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 · 1

    IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON (B)(6) 2021 AND A DRAIN WAS USED. DURING SURGERY, SOON AFTER INSERTING THE DRAIN TO THE PATIENT, THE RESERVOIR SWELLED, SO WHEN CHECKING THEM, THERE WAS A HOLE ON THE DRAIN. THE DRAIN WAS NOT FIXED WITH THE SUTURE YET, SO IT IS UNLIKELY THAT IT WAS HURT DURING THE OPERATION. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304676 BLAKE (R) DRAIN 10FR ROUND CATHETER, IRRIGATION GBX ETHICON INC. 2227 10705031003552

    Patients

    Seq Age Sex Outcome Treatment
    1