BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCRYL VIO 18IN 4-0 S/A P-3 PRM MP

    MDR report key: 7524694 · Received May 17, 2018

    Report

    Report Number
    2210968-2018-72884
    Event Type
    Malfunction
    Date Received
    May 17, 2018
    Date of Event
    April 17, 2018
    Report Date
    April 24, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    UDI-DI
    10705031059269
    PMA / PMN Number
    K960653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PC-(B)(4). DATE SENT TO THE FDA: (B)(4) 2018. AN EMPTY OPENED FOIL, A USED NEEDLE AND SUTURE PIECE WERE RETURNED FOR ANALYSIS. DURING THE VISUAL INSPECTION OF SAMPLE, THE SWAGE AND ATTACHMENT AREA WERE AS EXPECTED. THE BARREL HOLE OF THE NEEDLE IT WAS OBSERVED DAMAGED (CRUSHED). MARKS ON THE EDGE APPEARS TO BE BY THE USE OF A SURGICAL INSTRUMENT. THE SUTURE PIECE WAS EXAMINED ALONG OF THE STRAND AND DAMAGED (DENT) WERE OBSERVED ON THE END, ALSO THE END WAS CUT APPEARS TO BE BY THE USE OF A SURGICAL INSTRUMENT. ACCORDING TO THE SAMPLE CONDITION, THE ASSIGNABLE CAUSE OF PERFORMANCE-PULL OFF SUTURE NEEDLE, SUGGEST AN IMPROPER HANDLING OF SAMPLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH LD6909, MFG DATE: 04/27/2017, EXP DATE: 03/31/2022. BATCH LKZ626, MFG DATE: 09/18/2017, EXP DATE: 08/31/2022. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA. THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANIMAL UNDERWENT A DENTAL PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE POPPED OFF THE NEEDLE DURING A SIMPLE INTERRUPTED SUTURE LINE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE ANIMAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366202 MCRYL VIO 18IN 4-0 S/A P-3 PRM MP SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. UNK 10705031059269

    Patients

    Seq Age Sex Outcome Treatment
    1