BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAKE SI DRAIN HBLS 10FR RND W/ 1/8IN

    MDR report key: 22485181 · Received July 11, 2025

    Report

    Report Number
    2210968-2025-08086
    Event Type
    Malfunction
    Date Received
    July 11, 2025
    Report Date
    July 11, 2025
    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) D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. ADDITIONAL INFORMATION PROVIDED: LOT NUMBER UNK J230102, J2307553 QTY TO BE RETURNED OF (B)(4): 1 =10 QTY OF PRODUCT INVOLVED OF (B)(4): 1 = 2 ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED. WHAT IS THE LOT NUMBER? J230102/J2307553 WAS THE DRAIN USED ON THE PATIENT? NO, THE EVENT OCCURRED BEFORE USE. IF YES, WAS LEAKAGE DETECTED? WAS ANOTHER DRAIN NEEDED TO CORRECT THE SITUATION? UNK IF YES, WAS THE NEW DRAIN PLACED SURGICALLY DURING A SECOND PROCEDURE? PLEASE PERFORM AND DOCUMENT THE FOLLOW UP ATTEMPT FOR PRODUCT RETURN. WE REGULARLY CONTACT WITH SALE REP ABOUT THE DEVICE RETURNING. J230102 IS AN INVALID LOT NUMBER. PLEASE VERIFY AND PROVIDE CORRECT LOT NUMBER. UNK PLEASE CLARIFY HOW MANY DEVICES WILL BE RETURNED FOR EACH LOT NUMBER INVOLVED. UNK PLEASE PERFORM AND DOCUMENT THE FOLLOW UP ATTEMPT FOR PRODUCT RETURN. THE DEVICE HAS BEEN RECEIVED AT SUKAGAWA AND WILL BE SHIPPED. PLEASE CHECK RMAO. PLEASE PROVIDE THE SOURCE OR NAME AND TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP OR LOC/BQ) (B)(6). H3 EVALUATION: COMPLAINT SAMPLE REVIEW : TOTAL TWO COMPLAINT SAMPLES OF DRAIN WITH TROCARS WERE RECEIVED FOR EVALUATION, SAMPLE B- BOTH THE PRODUCTS WERE INSPECTED VISUALLY, AND FOUND THAT THERE WERE STICKING MARKS VISIBLE ON THE TROCARS. ALSO, THE DRAINS HAD SIMILAR CHIP-OFF MARKS. AS PER STANDARD PRACTICE, 100% FUNCTIONAL TEST AND 100% VISUAL INSPECTION WAS CARRIED OUT, BEFORE AND AFTER PACKING OF FINISHED GOODS, PRIOR TO THE PRODUCT RELEASE. THERE WAS NO SCOPE TO MISS SUCH DEFECT, AT MANUFACTURING / RELEASE STAGE. DOCUMENTS REVIEW : LOT UNKNOWN RETENTION SAMPLE REVIEW : LOT UNKNOWN REVIEW OF DEFECTIVE SAMPLE'S IMAGE / VIDEO : NOT APPLICABLE, AS THERE WAS NO COMPLAINT SAMPLE IMAGE / VIDEO RECEIVED FOR EVALUATION. 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 A PATIENT UNDERWENT AN UNKNOWN ENT (EYES, NOSE, AND THROAT) SURGERY/AN UNKNOWN HEAD AND NECK SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. THE DRAIN HAD ADHERED TO THE TROCAR NEEDLE. THIS EVENT WAS FOUND BEFORE USE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. UPON RECEIPT AND ANALYSIS, IT WAS NOTED STICKING MARKS VISIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996868 BLAKE SI DRAIN HBLS 10FR RND W/ 1/8IN CATHETER, IRRIGATION GBX ETHICON INC. 10705031003552

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown