BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL PLUS UD 27IN USP4-0

    MDR report key: 11199013 · Received January 19, 2021

    Report

    Report Number
    2210968-2021-00484
    Event Type
    Malfunction
    Date Received
    January 19, 2021
    Date of Event
    January 1, 2020
    Report Date
    December 24, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K050845
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 2/11/2021. THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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 INFORMATION: H6. ADDITIONAL H3 INVESTIGATION SUMMARY: AN EMPTY OPENED FOIL, A PAPER LID, A LABELED WINDING FORMER, A DETACHED NEEDLE AND A SUTURE OF PRODUCT CODE MCP4260, LOT # PPMBPJ WERE RECEIVED FOR EVALUATION. DURING THE VISUAL INSPECTION OF THE NEEDLE, THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED, THE EDGE OF THE BARREL HOLE COULD BE OBSERVED WITH MARKS THAT APPEARS TO BE BY USE OF THE SURGICAL INSTRUMENT. THE END OF THE SUTURE WAS NOTED WITH DAMAGED CAUSED BY USE OF A SURGICAL INSTRUMENT. THE CONDITION OF THE SAMPLE RECEIVED INDICATE AN IMPROPER HANDLING OF THE DEVICE. 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. COMPLAINT INFORMATION WILL BE INCLUDED IN COMPLAINT TRENDING THAT IS REVIEWED ON A REGULAR BASIS TO DETERMINE IF FURTHER ACTION IS NECESSARY. TRADE NAME - IRGACARE®, ACTIVE INGREDIENT(S) ¿ TRICLOSAN, DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL, STRENGTH ¿ = 2360 G/M.

    Additional Manufacturer Narrative · 1

    (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE SNAPPED FROM SWAGE AFTER TAKING FIRST PASS ON THE SKIN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89162 MONOCRYL PLUS UD 27IN USP4-0 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. PPMBPJ

    Patients

    Seq Age Sex Outcome Treatment
    1