BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE (R) DRAIN 19FR R/F

    MDR report key: 11362060 · Received February 22, 2021

    Report

    Report Number
    2210968-2021-01665
    Event Type
    Injury
    Date Received
    February 22, 2021
    Report Date
    January 27, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GBX
    UDI-DI
    10705031003606
    PMA / PMN Number
    CL I EXEMPT
    Adverse Event
    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: 03/17/2021. 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 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. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: DATE OF PROCEDURE? NO FURTHER INFORMATION IS AVAILABLE. WERE ANY ANOMALIES NOTED OF THE DRAIN CONDITION UPON PLACEMENT? NO FURTHER INFORMATION IS AVAILABLE. DID THE DRAIN FUNCTION AS INTENDED? NO FURTHER INFORMATION IS AVAILABLE. IT WAS STATED A DRAIN WAS ""RE-INSERTED"". WAS A 2ND SURGICAL PROCEDURE PERFORMED TO PLACE ANOTHER DRAIN? NO FURTHER INFORMATION IS AVAILABLE. WHAT DATE WAS THE 2ND DRAIN PLACED? NO FURTHER INFORMATION IS AVAILABLE. DID THE DRAIN COME INTO CONTACT WITH ANY SHARP OBJECTS DURING/AFTER PLACEMENT? NO FURTHER INFORMATION IS AVAILABLE. PLEASE PROVIDE PATIENT DEMOGRAPHIC INFORMATION: AGE, GENDER, WEIGHT, BMI AT THE TIME OF THE INDEX PROCEDURE? NO FURTHER INFORMATION IS AVAILABLE. WHAT IS THE CURRENT STATUS OF THE PATIENT? NO FURTHER INFORMATION IS AVAILABLE. NO FURTHER INFORMATION WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED UPON INITIAL REPORTED EVENT: IT IS CONSIDERED THAT THE CHEST DRAIN WAS PULLED WHEN THE PATIENT SUDDENLY CHANGED FROM THE SUPINE POSITION TO THE SITTING POSITION AND TRIED TO MOVE BY HIMSELF, RESULTING IN CUTTING BY TENSION. FURTHER DETAILS ARE NOT PROVIDED. NO SAMPLE WILL BE RETURNED. IT IS CONSIDERED THAT SOME EXTERNAL FORCE WAS APPLIED AROUND 10 CM FROM THE INSERTION SITE OF THE CHEST DRAIN. THE POSSIBILITY CANNOT BE RULED OUT THAT THERE WAS A PROBLEM WITH THE CHEST DRAIN ITSELF. REGARDING THE SPONTANEOUS REMOVAL OF THE RESIDUAL DRAIN AFTER AMPUTATION, IT IS CONSIDERED THAT THE DRAIN WAS COMPLETELY REMOVED DUE TO INSUFFICIENT FIXATION AND RETENTION OF THE DRAIN FORCEPS. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. INFORMED THE PRODUCT WILL NOT BE RETURNED. 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 LUNG RESECTION PROCEDURE ON AN UNKNOWN DATE AND A DRAIN WAS USED. THE RIGHT UPPER LOBE LUNG ADENOCARCINOMA, AND A CHEST DRAIN WAS INSERTED AFTER SURGERY. ON POSTOPERATIVE DAY 1, THE PATIENT VOMITED AND WAS ABOUT TO DESCEND THROUGH THE GAP BETWEEN THE BED RAILS ON THE FOOT SIDE. WHEN THE CHEST TUBE WAS CHECKED, THE CHEST TUBE WAS CUT AT ABOUT 10 CM FROM THE INSERTION SITE. IMMEDIATELY, THE REMAINING DRAIN WAS CLAMPED WITH DRAIN FORCEPS. THE SUTURE THAT SHOULD HAVE BEEN AT THE PUNCTURE SITE DEVIATED BY ABOUT 2 CM AND FELL OUT BY ABOUT 5 CM. FOR CHEST X-RAY, THE PATIENT WAS MOVED TO A WHEELCHAIR WHILE HOLDING THE DRAIN FORCEPS. THE CHEST DRAIN WAS COMPLETELY REMOVED WHEN THE PATIENT WAS STANDING FOR IMAGING. DYSPNOEA AND DECREASED OXYGEN SATURATION WERE NOT OBSERVED, BUT CHEST X-RAY SHOWED LUNG COLLAPSE, AND THEREFORE CHEST DRAIN WAS RE-INSERTED. IT IS CONSIDERED THAT THE CHEST DRAIN WAS PULLED WHEN THE PATIENT SUDDENLY CHANGED FROM THE SUPINE POSITION TO THE SITTING POSITION AND TRIED TO MOVE BY HIMSELF, RESULTING IN CUTTING BY TENSION. FURTHER DETAILS ARE NOT PROVIDED. NO SAMPLE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255115 BLAKE (R) DRAIN 19FR R/F CATHETER, IRRIGATION GBX ETHICON INC. 2232 10705031003606

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention