BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL+ CT SUT 1X54IN(135CM) 3-0 VIO

    MDR report key: 11573086 · Received March 25, 2021

    Report

    Report Number
    2210968-2021-02760
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Date of Event
    January 1, 2021
    Report Date
    March 3, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031051584
    PMA / PMN Number
    K132580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # : (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. TRADE NAME - IRGACARE®. ACTIVE INGREDIENT(S): TRICLOSAN. DOSAGE FORM: SUTURE/SOLID/PARENTERAL. STRENGTH: 472 G/M VICRYL. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: COULD YOU PLEASE PROVIDE MORE INFORMATION REGARDING HOW THIS IS AFFECTING SURGICAL APPLICATION, ETC? THIS AFFECTS SURGICAL EFFICIENCY ESPECIALLY WITH BIG CASES WHERE YOU WILL HAVE MULTIPLE REELS ON A SETUP AND WHEN YOU'RE QUICKLY LOOKING FOR A 2/0 REEL BUT MISTAKENLY HAND UP THE 3/0-REEL BC IT ONLY HAS 2 DOTS INSTEAD OF 3 AND THEN THE SURGEON GETS UPSET DUE TO BEING GIVEN THE WRONG REEL. DOES THIS PROBLEM OCCUR FOR BOTH PRODUCT CODES VCP205G AND J206G OR ONLY FOR VCP205G? THE ISSUE WAS WITH VCP205 (THE ENTIRE BOX). HOW MANY "2 DOTS INSTEAD OF 3 " ISSUE OCCURRED DURING SUTURING ON THIS ONE PATIENT DURING THIS SINGLE SURGERY? TWICE BC WE ONLY OPENED 2, THIS IS A REEL, NOT A SUTURE. DID THE "2 DOTS INSTEAD OF 3 " ISSUE OCCUR WITH ALL 7 RETURNING VCP205G DEVICES DURING THIS SINGLE SURGERY? WE ONLY OPENED 2 FOR THE SURGERY AND A 3RD TO SEE IF THE WHOLE BOX WAS FAULTY, WE WOULD NOT SEND YOU USED ITEMS AS THEY WOULD BE CONTAMINATED WITH BLOOD AND TISSUE. IF NOT, AND THE ISSUE OCCURRED IN MULTIPLE PROCEDURES, WE'LL HAVE TO LOG ADDITIONAL CASES TO CAPTURE- ONLY 1 CASE AS WE TOOK THE AFFECTED BOX OUT OF CIRCULATION WHEN WE DISCOVERED THE FAULT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, THE 3 0 VICRYL REELS (NEW BOX) HAVE 2 DOTS INSTEAD OF THE NORMAL 3. THE THREAD IS APPROPRIATE BUT JUST THE DOTS ARE NOT. THE PRODUCT WAS NOT RETURNED TO ETHICON INC FOR EVALUATION. VISUAL INSPECTION WAS CONDUCTED ON THE PICTURES RECEIVED. VISUAL ANALYSIS OF THE PICTURES RECEIVED DETERMINED THAT MIXED REELS DEFECT COULD BE OBSERVED IN THE SAMPLE OF PRODUCT CODE VCP205. SINCE THE SPOOL/REEL HAD TWO HOLES PUNCHED AND FOR PRODUCT CODE VCP205 SHOULD BE THREE HOLES PUNCHED. IN ADDITION, THE SAMPLE IDENTIFIED WITH THE CODE J206 IS USED TO COMPARE THE CONDITION. THE WRONG AND/OR MIXED REELS DEFECT HAS BEEN CORRELATED TO THE MANUFACTURING PROCESS. 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. BASED ON THE INFORMATION CURRENTLY AVAILABLE, THE WRONG AND/OR MIXED REELS WAS IDENTIFIED DURING THE INVESTIGATION OF THE SAMPLES RECEIVED. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH ETHICON INC¿S QUALITY SYSTEM. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE., VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT SEVEN UNOPENED SAMPLES OF PRODUCT CODE VCP205 WERE RECEIVED FOR EVALUATION. MIXED REELS DEFECT COULD BE OBSERVED IN THE SAMPLES. THE VISUAL INSPECTION CONCLUDED THAT THE SPOOL/REEL HAD TWO HOLES PUNCHED AND FOR PRODUCT CODE, VCP205 SHOULD BE THREE HOLES PUNCHED. DUE TO A MISMATCH AT THE SPOOL, A CHARACTERIZATION OF THE SUTURE WAS PERFORMED AND MEET THE REQUIREMENTS FOR A VICRYL SUTURE DIAMETER 3-0¿. THE WRONG AND/OR MIXED REELS DEFECT HAS BEEN CORRELATED TO THE MANUFACTURING PROCESS. 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. BASED ON THE INFORMATION CURRENTLY AVAILABLE, THE WRONG AND/OR MIXED REELS WERE IDENTIFIED DURING THE INVESTIGATION OF THE SAMPLES RECEIVED. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH ETHICON INC¿S QUALITY SYSTEM. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. RELATED MEDWATCH REPORTS: 2210968-2021-02759, 2210968-2021-02760.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE IT WAS NOTED THAT A SIZE 3-0 SUTURE HAD TWO HOLES PUNCHED IN THE REELS. THE THREAD WAS APPROPRIATE BUT JUST THE DOTS WERE NOT. IT WAS NOTED DURING PHOTO EVALUATION THAT THE REEL HAD TWO HOLES PUNCHED AND IT SHOULD BE THREE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469517 VCL+ CT SUT 1X54IN(135CM) 3-0 VIO SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. VCP205G QCMEMX 10705031051584

    Patients

    Seq Age Sex Outcome Treatment
    1