BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL CT BRD VIO 36IN 0 S/A CP-1

    MDR report key: 17169984 · Received June 21, 2023

    Report

    Report Number
    2210968-2023-04473
    Event Type
    Malfunction
    Date Received
    June 21, 2023
    Date of Event
    June 12, 2023
    Report Date
    August 4, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031040274
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WAS THERE ANY ADVERSE CONSEQUENCE ASSOCIATED WITH THE PATIENT? WHAT TISSUE STRUCTURE THE BROKEN NEEDLE IS LOCATED? WERE X-RAYS TAKEN TO LOCATE THE NEEDLE PIECE(S)? WAS THERE ANY ADDITIONAL TISSUE DAMAGE AS A RESULT OF SEARCHING FOR THE NEEDLE PIECE? ARE ANY PLANS IN PLACE TO REMOVE THE NEEDLE PIECE IN FUTURE? IF YES PLEASE PROVIDE THE SURGERY DATE (MM/DD/YYYY) WHAT IS THE SURGEON'S OPINION OF CONSEQUENCES TO THE PATIENT? WHAT IS THE CURRENT STATUS OF THE PATIENT? A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4); DATE SENT TO THE FDA: 8/4/2023; H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND. H3 INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. THE RETURNED SAMPLE REVEALED THAT IT WAS RECEIVED TEN UNOPENED SAMPLES THAT PERTAIN TO PRODUCT CODE J473. IN ORDER TO EVALUATE THE CONDITION OF THE RETURNED SAMPLES, THE PACKETS WERE OPENED, THE CLOSURE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE TIP AND BODY OF THE NEEDLES WERE EXAMINED UNDER MAGNIFICATION AND NO DEFECTS OR NEEDLE BREAKAGE WERE FOUND. IN ADDITION, THE SAMPLES WERE TESTED BY RESISTANCE TEST TO NEEDLE AND MET THE REQUIREMENTS. AS PART OF ETHICON QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE POINT OF THE NEEDLE (NEEDLE TIP) BROKE DURING DEEP SUTURING, AT THE LEVEL OF THE APONEUROSIS, AND THE SURGICAL TEAM DID A MANUAL SEARCH WITH THE USE OF THE IMAGE INTENSIFIER AND WERE UNABLE TO FIND THIS NEEDLE PART. NEEDLE WAS LOCATED SEVERAL TIMES WITH THE AMPLIFIER BUT NOT FOUND. USE ALSO OF A MAGNET IN SITU BUT NOT FOUND. SURGEON'S DECISION TO CLOSE THE OPERATIVE WOUND WITHOUT HAVING THE MISSING NEEDLE FRAGMENT. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1998726 VCL CT BRD VIO 36IN 0 S/A CP-1 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. J473H TDBDKTW0 10705031040274

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown