BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL CT BRD UD 18IN 4-0 S/A PC-3 PRM

    MDR report key: 15202921 · Received August 10, 2022

    Report

    Report Number
    2210968-2022-06476
    Event Type
    Malfunction
    Date Received
    August 10, 2022
    Date of Event
    July 18, 2022
    Report Date
    August 29, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: HOW MANY SUTURE DISCONNECTED FROM NEEDLE DURING THIS SINGLE PROCEDURE? PLEASE CLARIFY. 3 SUTURES DISCONNECTED FROM NEEDLE DURING THIS SINGLE PROCEDURE. \SPECIFICALLY FOR THIS SINGLE PROCEDURE PLEASE CONFIRM IF THE QUALITY ISSUE OCCURRED INTRA-OP OR PRE-OP. INTRA-OP. WAS THERE ANY PATIENT CONSEQUENCE OR INJURY? UNKNOWN. DEVICE RETURN STATUS? DEVICES ARE AVAILABLE FOR RETURN. WE WILL SHIPPED THE DEVICE ONCE RECEIVED AT OUR END. WAS THERE A SURGICAL DELAY IN RELATION TO THE REPORTED EVENT? IF YES, HOW MANY MINUTES WAS THE DELAY? UNKNOWN. WAS OTHER MEDICAL INTERVENTION REQUIRED? IF YES, PLEASE SPECIFY DETAILS. NO. WAS THE SURGERY COMPLETED SUCCESSFULLY? (YES OR NO): YES. PLEASE PROVIDE PATIENT STATUS/ OUTCOME (PLEASE DESCRIBE IF ANY PATIENT HARM OCCURRED AND WHAT IS THE PATIENT¿S CONDITION POST-SURGERY): UNKNOWN. WERE THE BROKEN FRAGMENTS RETAINED IN THE PATIENT? (YES OR NO): IF YES, DID IT INVOLVE ADDITIONAL INTERVENTION TO REMOVE RETAINED FRAGMENTS? (YES OR NO): NO. ADDITIONAL INFORMATION WAS REQUESTED: ORIGINALLY 8 DEVICES WERE REPORTED. IT WAS CONFIRMED THAT 3 DEVICES EXPERIENCED NEEDLE PULL OFF. PLEASE CONFIRM IF 5 OTHER SUTURES EXPERIENCED ANOTHER TYPE OF QUALITY ISSUE OR DID NOT EXPERIENCE A QUALITY ISSUE DURING THIS PROCEDURE. 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. RELATED TO: 2210968-2022-06477, 2210968-2022-06478.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 8/29/2022. H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND. H3 INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TEST EVALUATION WERE CONDUCTED ON THE RETURNED DEVICES. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT ONE EMPTY FOIL AND A SUTURE OF PRODUCT CODE W9783 WERE RECEIVED. THE VISUAL ASSESSMENT OF THE SUTURE NOTED THAT THE END WAS CUT APPEARS TO BE BY A SURGICAL INSTRUMENT, THE EXTREME OF THE SUTURE WAS OBSERVED WITH BODY FLUIDS AND OPEN FILAMENT DUE TO THE TIPPED SUTURE END. IN ADDITION, THE NEEDLE WAS NOT RETURNED FOR ANALYSIS TO DETERMINE THE ASSIGNABLE CAUSE. ALTHOUGH NO CONCLUSION COULD BE REACH ON THE CAUSE OF THE REPORTED EVENT. AS PART OF ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. ADDITIONAL H3 INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TEST EVALUATION WERE CONDUCTED ON THE RETURNED DEVICES. FIVE UNOPENED SAMPLES OF PRODUCT CODE W9783 WERE RETURNED FOR ANALYSIS. IN ORDER TO EVALUATE THE CONDITION OF THE RETURNED SAMPLES, THE PACKETS WERE OPENED, AND THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG OF THE STRAND NO ANOMALIES WERE OBSERVED DURING EVALUATION. FUNCTIONAL TEST WAS PERFORMED, AND THE PULL FORCE RESULT WERE ABOVE THE MINIMUM REQUIREMENTS. AS PART OF QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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. RELATED TO: 2210968-2022-06476, 2210968-2022-06477, 2210968-2022-06478.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DISCONNECTED FROM NEEDLE AFTER DOING FIRST STITCH ON THE SKIN. 3 DEVICES EXPERIENCED NEEDLE PULL OFF. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429325 VCL CT BRD UD 18IN 4-0 S/A PC-3 PRM SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. QPMDQP

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown