BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAKE (R) DRAIN 15FR R/F

    MDR report key: 11311493 · Received February 10, 2021

    Report

    Report Number
    2210968-2021-01290
    Event Type
    Malfunction
    Date Received
    February 10, 2021
    Date of Event
    January 18, 2021
    Report Date
    January 21, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GBX
    UDI-DI
    10705031003576
    PMA / PMN Number
    CL I EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 4/14/2021. ADDITIONAL INFORMATION: D9. CORRECTED DATA: D3. H3 EVALUATION: COMPLAINT SAMPLE WAS RECEIVED. DURING EVALUATION OF COMPLAINT SAMPLE, ADHESION MARKS OF DRAIN WERE OBSERVED ON THE TROCAR AND SMALL HOLE ON THE DRAIN. COMPLAINT IS VERIFIED THE ACTIONS HAVE BEEN DOCUMENTED IN DMD CAPA 2/20. 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: 4/14/2021. CORRECTED DATA: D3. 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 · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO FDA: 3/3/2021. ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. H3 EVALUATION: COMPLAINT SAMPLE WAS NOT RECEIVED TO DATE FOR EVALUATION. RETAIN SAMPLE OF THE SAME LOT NO. WERE CHECKED VISUALLY AND FOUND WITHIN THE SPECIFIED CRITERIA. THERE WAS NO STICKINESS OBSERVED BETWEEN TROCAR NEEDLE AND DRAIN. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC 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 WAS REQUESTED HOWEVER AND WAS RECEIVED. TO DATE THE PRODUCT HAS NOT BEEN RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE CONFIRM, WAS THE DRAIN PLACED IN THE PATIENT? YES. WAS LEAKAGE DETECTED WHEN ACTIVATING? YES. HOW WAS THE ISSUE NOTICED? LEAKAGE DETECTED WHEN ACTIVATED. HOW WAS THE CASE COMPLETED? USED ANOTHER DRAIN. WAS THE DAMAGED DRAIN REMOVED SURGICALLY? NO. WAS A NEW DRAIN NEEDED TO BE IMPLANTED DURING A SECOND SURGERY? NO. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THIS LOT. 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 A ABDOMINOPLASTY ON (B)(6) 2021 AND A DRAIN WAS USED. THE DRAIN TUBING WAS STUCK OR MELTED TO THE SIDE OF THE TROCAR. THE DRAIN PLACED IN THE PATIENT. A LEAKAGE WAS DETECTED WHEN ACTIVATING. WHEN THE SURGEON ATTEMPTED TO PULL THE TWO APART, IN CREATED A SMALL HOLE IN THE SILICONE TUBING RENDERING IT UNUSABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207977 BLAKE (R) DRAIN 15FR R/F CATHETER, IRRIGATION GBX ETHICON INC. 2229 J1922085 10705031003576

    Patients

    Seq Age Sex Outcome Treatment
    1