BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL CT BRD UD 18IN 5-0 S/A PS-2 PRM MP

    MDR report key: 18840421 · Received March 5, 2024

    Report

    Report Number
    2210968-2024-02426
    Event Type
    Malfunction
    Date Received
    March 5, 2024
    Date of Event
    January 1, 2024
    Report Date
    March 22, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031040557
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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. 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: IT WAS REPORTED THAT "DR. HAS HAD A PROBLEM WITH THE J495 5-0 SUTURE THAT SHE USES FOR SOME OF HER PROCEDURES. THE NEEDLE HAS POPPED OFF A NUMBER OF TIMES. " PLEASE CONFIRM THE NUMBER OF PROCEDURES AFFECTED BY THIS ISSUE. 4-5 DIFFERENT PROCEDURES. IF POSSIBLE, PLEASE CONFIRM THE NUMBER OF "POP-OFFS" PER PROCEDURE. 1-3 CAN YOU IDENTIFY THE LOT NUMBER OF THE PRODUCTS THAT WERE USED? SLMSJZ, RPMDLL WHEN DID THE NEEDLE DETACH/PULL OFF FROM THE SUTURE (IN THE PACKAGE, DURING REMOVAL FROM THE PACKAGE, DURING HANDLING BEFORE USE ON PATIENT OR DURING USE ON THE PATIENT)? PLEASE SPECIFY DURING PROCEDURE, WHILE RUNNING THE SUTURE. ARE THE DEVICES OR SAMPLES FROM THE SAME LOT AVAILABLE FOR ANALYSIS? IF YES, TO WHOM SHOULD THE SHIPPER KIT BE SENT? (PLEASE PROVIDE CONTACT NAME, DEPARTMENT, STREET ADDRESS INCLUDING ZIP, NO PO BOX PLEASE, EMAIL ADDRESS, AND PHONE NUMBER) YES, DR. JENNIFER HARRINGTON, 2805 CAMPUS DRIVE, SUITE 485, PLYMOUTH, MN 55441 PLEASE PROVIDE THE SOURCE OR NAME AND TITLE OF THE EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP) CHAD SMITH, PRACTICE DIRECTOR, PRACTICE DIRECTOR POSSIBLE LOTS: SLMSJZ, RPMDLL. EVENTS REPORTED VIA: MWR-13022024-0001572642, MWR-13022024-0001572643, MWR-13022024-0001572645.

    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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE SLMSJZ / J495G11 BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. EXPIRATION DATE: SEP/30/2027 DATE OF MFG.: OCT/28/2022. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE RPMDLL / VCP107V30 BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. EXPIRATION DATE: NOV/30/2026 DATE OF MFG.: DEC/8/2021.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER REPORTED THAT DR. HARRINGTON HAS HAD A PROBLEM WITH THE J495 5-0 SUTURE THAT SHE USES FOR SOME OF HER PROCEDURES. THE NEEDLE HAS POPPED OFF A NUMBER OF TIMES. THEY HAVE TRIED DIFFERENT LOT NUMBERS WITH NO FIX. THEY PULLED OUT ONE EACH OF THE J495, A 4-0 J496 AND A 6-0 J492 AND TESTED THEM BY PULLING ON THE SUTURE UNTIL NEEDLE POP OFF. THERE WAS A SIGNIFICANT EASE OF POP OFF WITH THIS 5-0 THAN THE OTHER TWO SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518931 VCL CT BRD UD 18IN 5-0 S/A PS-2 PRM MP SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. SLMSJZ, RPMDLL 10705031040557

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown