BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL+ VIO 36IN 0 S/A CT-1

    MDR report key: 12869676 · Received November 24, 2021

    Report

    Report Number
    2210968-2021-12062
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    October 29, 2021
    Report Date
    November 24, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031052574
    PMA / PMN Number
    K132580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER RJ2ABS AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. (B)(4). INVESTIGATION SUMMARY: FIVE PACKETS OF PRODUCT CODE VCP346 WERE RETURNED TO ETHICON INC FOR ANALYSIS (FOUR WITH THE PACKAGING CLOSED AND ONE WITH THE FOIL OPENED). UPON INITIAL INSPECTION TO THE SAMPLE NO EXTERNAL DAMAGES WERE OBSERVED ON THE PACKET. THE COMPLAINT SAMPLE WAS NOT RECEIVED. IN ORDER TO EVALUATE THE CONDITIONS OF THE RETURNED SAMPLES, THE PACKET WAS OPENED, AND NO DEFECTS WERE DETECTED. THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE NEEDLES WERE INTACT AND NO DAMAGES, BREAKAGE ON BODY, TIP OR SWAGE AREA WERE OBSERVED DURING EVALUATION. FUNCTIONAL TEST WAS PERFORMED, TO NEEDLE BY RESISTANCE AND MET THE 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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT DO YOU MEAN BY " THE TIP OF THE NEEDLE WAS MISSING"? PLEASE EXPLAIN EXACTLY WHAT I SAID. FIRST 1/4 OF NEEDLE TIP MISSING/ BROKEN OFF WHEN THEY OPENED PACKAGE- COULDN¿T FIND TIP. DID THE NEEDLE GOT BROKEN? PLEASE EXPLAIN IN DETAILS. IT WAS BROKEN. 1/4 OF TIP WAS OFF. COULD YOU PLEASE CONFIRM IF THE WHOLE NEEDLE WAS MISSING? NO THE WHOLE NEEDLE WAS NOT MISSING- JUST FIRST 1/4 OF TIP. TRADE NAME - IRGACARE®, ACTIVE INGREDIENT(S) ¿ TRICLOSAN, DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL, STRENGTH ¿ = 275 G/M.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN REMOVING THE SUTURE, THE TIP OF THE NEEDLE WAS MISSING. THE SUTURE WAS DISCARDED AND ANOTHER SUTURE OF A DIFFERENT CODE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768760 VCL+ VIO 36IN 0 S/A CT-1 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. VCP346H RJ2ABS 10705031052574

    Patients

    Seq Age Sex Outcome Treatment
    1 Female