BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK SUTURE 30"(75CM) 2 BLK

    MDR report key: 14862726 · Received June 29, 2022

    Report

    Report Number
    2210968-2022-04981
    Event Type
    Malfunction
    Date Received
    June 29, 2022
    Date of Event
    June 2, 2022
    Report Date
    August 1, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    UDI-DI
    10705031044517
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: HOW WAS THE PRODUCT PURCHASED?? MEDLINE. IS THERE ANY INDICATION THIS CAN BE LABELING IDENTIFICATION ISSUE, MEANING LABELING PROVIDES INCORRECT PRODUCT INFORMATION? THERE IS A MIS-PACKAGING ISSUE. THE CUSTOMER ORDERED THE CORRECT PRODUCT WITH THE MH NEEDLE ON MEDLINE, BUT THEN RECEIVED CT-1 NEEDLE. EVENT DATE? ON (B)(6) 2022. LOT NUMBER? SAMMSB FOR ALL THREE BOXES. EVENTS REPORTED VIA: 2210968-2022-04982 AND 2210968-2022-04983.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 8/1/2022. H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND. H6 COMPONENT CODE: C22 - PHOTO ANALYSIS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3 INVESTIGATIONAL SUMMARY ¿ PHOTO ANALYSIS: THIS IS AN ANALYSIS OF A SET OF PHOTOS SUBMITTED TO ETHICON FOR EVALUATION. DURING THE VISUAL ANALYSIS THE FOLLOWING WAS OBSERVED: THE PHOTOS SHOW THREE SEALED BOXES OF PRODUCT CODE K846H, LOT # SAMMSB FOR EVALUATION AND A PHOTO WITH A PURCHASE SCREEN. THE IMAGE IS NOT CLEAR TO DETERMINE THE EVENT. BASED ON VISUAL INSPECTION OF PHOTOS RELATED TO PRODUCT CODE K846H, LOT # SAMMSB AND NEEDLE SALES TYPE BELONGS TO CT-1, PRODUCT MANUFACTURED ON JAN/24/2022 AND EXPIRATION DATE ON DEC/31/ 2026. DURING THE PACKAGING PROCESS, EACH BARCODE ON THE BOX AND LABEL IS SCANNED INTO THE SYSTEM TO COMPARE PRINT INFORMATION. FURTHERMORE, THE COMPONENTS ASSIGNED TO EACH BATCH WERE CORRECT. ACCORDING TO THE RESULTS OBTAINED DURING THE INVESTIGATION, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. AS PART OF OUR QUALITY PROCESS, MANUFACTURING RECORDS WERE REVIEWED FOR THIS LOT'S SERIAL NUMBER AND MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS LOT. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE 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) 2022 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT THE CUSTOMER HAS RECEIVED THEIR ORDER OF SILK SUTURES WITH THE SELECTION OF MH NEEDLE TYPE, BUT THEY RECEIVED CT-1 NEEDLE TYPE INSTEAD. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153943 SILK SUTURE 30"(75CM) 2 BLK SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. K846H SAMMSB 10705031044517

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown