BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCRYL VIO 27IN 3-0 S/A RB-1 MP

    MDR report key: 13179480 · Received January 6, 2022

    Report

    Report Number
    2210968-2022-00134
    Event Type
    Malfunction
    Date Received
    January 6, 2022
    Date of Event
    December 14, 2021
    Report Date
    March 10, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    UDI-DI
    10705031058712
    PMA / PMN Number
    K960653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 2/25/2022. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: LOT NUMBER: UNKNOWN: PPMCHL. QTY TO BE RETURNED: 1: 7. 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. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 3/10/2022. H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3 INVESTIGATIONAL NARRATIVE: VISUAL ANALYSIS OF THE RETURNED PRODUCT REVEALED THAT ONE OPENED SAMPLE PRODUCT CODE Y305H WAS RECEIVED TO ETHICON INC FOR EVALUATION. THE SUTURE HAS BEGUN WITH PROCESS DEGRADATION CAUSED BY EXPOSURE TO THE ENVIRONMENT AND THE NEEDLE DETACHED FROM THE STRAND. THE PRODUCT CODE Y305H CONTAINS AN ABSORBABLE SUTURE. AS THE SAMPLE WAS RECEIVED OPEN, THE TIME OF EXPOSURE TO THE ENVIRONMENT COULD NOT BE DETERMINED AND FUNCTIONAL TESTS CANNOT BE PERFORMED. IN ADDITION, THE FOIL PACKET WAS NOT RECEIVED FOR EVALUATION. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED, AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. AS PART OF ETHICON 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. ADDITIONAL H3 INVESTIGATIONAL NARRATIVE: THREE PACKETS OF PRODUCT CODE Y305H WERE RETURNED TO ETHICON INC FOR ANALYSIS WITH THE PACKAGING CLOSED. UPON INITIAL INSPECTION, OF THE SAMPLE, NO EXTERNAL DAMAGES WERE OBSERVED ON THE PACKET. IN ORDER TO EVALUATE THE CONDITIONS OF THE RETURNED SAMPLES, THE PACKETS WERE OPENED, AND NO DEFECTS WERE DETECTED. THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG THE STRANDS TO DETECT ANY ISSUE ON THE SUTURES AND NO DEFECTS WERE OBSERVED DURING EVALUATION. FUNCTIONAL TEST WAS PERFORMED, AND THE PULL FORCE RESULTS WERE ABOVE THE MINIMUM REQUIREMENTS. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED, AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. AS PART OF ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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). 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: PRODUCT CODE: Y305H. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: PLEASE PROVIDE PROCEDURE NAME. NO FURTHER INFORMATION IS AVAILABLE. PLEASE PROVIDE LOT NUMBER. NO FURTHER INFORMATION IS AVAILABLE. NO FURTHER INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PEDIATRIC SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51693 MCRYL VIO 27IN 3-0 S/A RB-1 MP SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. Y305H PPMCHL 10705031058712

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown