BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE BLUE 0.7M 60CM W/NDL

    MDR report key: 18993916 · Received March 28, 2024

    Report

    Report Number
    2210968-2024-03546
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Report Date
    June 26, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. 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 THE ITEM USED IN SURGERY? WHEN WAS THE ISSUE NOTICED (PRE-OP, INTRA-OP)? WAS THERE ANY PATIENT CONSEQUENCE? WHAT IS THE CURRENT STATUS OF THE PATIENT? ATTEMPTS ARE BEING 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. COMPONENT CODE: G07002 DEVICE NOT RETURNED. RELATED EVENTS CAPTURED VIA: 2210968-2024-03545. AND 2210968-2024-03547.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). DATE SENT TO THE FDA: 5/6/2024. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED, AND NO RELATED NON-CONFORMANCES WERE. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: * WAS THE ITEM USED IN SURGERY? NO. * WHEN WAS THE ISSUE NOTICED (PRE-OP, INTRA-OP)? PRE-OP. * WAS THERE ANY PATIENT CONSEQUENCE? NO. 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.

    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. H6 COMPONENT CODE: C22 - PHOTO ANALYSIS. PHOTO REVIEW: THIS IS AN ANALYSIS FOR A PHOTO SUBMITTED TO ETHICON FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE PHOTO SHOWS A PACKAGE LABELED AS W8718 WITH AN FOREIGN MATTER INSIDE STERILE BARRIER. A CLEAR ANALYSIS COULD NOT BE PERFORMED AS THE PHOTO BECOMES DISTORTED WHEN MAGNIFIED. BASED ON THE PHOTO REVIEW, NO CONCLUSION OR ROOT CAUSE COULD BE DETERMINED. HANDS ON DEVICE ANALYSIS MAY PROVIDE THE ADDITIONAL EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE OF THE REPORTED EVENT. BECAUSE THE DEVICE WAS NOT RETURNED OUR EVALUATION IS LIMITED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. THERE WAS "HAIR" INSIDE THE SEALED PACKET OF A 6-0 PROLENE. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1370185 PROLENE BLUE 0.7M 60CM W/NDL SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. TJBDXD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown