BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22485180 · Received July 11, 2025

    Report

    Report Number
    2210968-2025-08085
    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). ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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. ? 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 A- 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 : DURING INVESTIGATION OF COMPLAINT, BATCH REVIEW OF IN-PROCESS AND FINAL PACKAGING INSPECTIONS, AS WELL AS THE MANUFACTURING PROCESS IS PERFORMED, THESE PRODUCTS ARE REPORTED TO BE MANUFACTURED, INSPECTED, AND PACKAGED IN CONFORMANCE WITH CUSTOMER'S SPECIFICATIONS AND HAVE BEEN FOUND TO BE ACCEPTABLE WITHIN ALL PARAMETERS. NO DISCREPANCY AS PER THE REPORTED DEFECT IS OBSERVED. RETENTION SAMPLE REVIEW : NO NEGATIVE OBSERVATION WAS FOUND. REVIEW OF DEFECTIVE SAMPLE'S IMAGE / VIDEO : NOT APPLICABLE, AS THERE WAS NO COMPLAINT SAMPLE IMAGE / VIDEO RECEIVED FOR EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THIS LOT. 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
    996867 BLAKE SI DRAIN HBLS 10FR RND W/ 1/8IN CATHETER, IRRIGATION GBX ETHICON INC. J2307553 10705031003552

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown