BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFX SYM PDS+ UNI VIO 18IN 1 S/A CTB-1

    MDR report key: 13101405 · Received December 28, 2021

    Report

    Report Number
    2210968-2021-13033
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Report Date
    December 28, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031227712
    PMA / PMN Number
    K113004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT NUMBER: (B)(4). THE FOLLOWING INFORMATION WAS REQUESTED, BUT WAS UNAVAILABLE: PLEASE PROVIDE THE LOT NUMBER. NO FURTHER INFORMATION IS AVAILABLE. PROCEDURE NAME AND DATE? NO FURTHER INFORMATION IS AVAILABLE. PLEASE PROVIDE THE STATUS OF THE DEVICE(S) AS IT HAS NOT BEEN RECEIVED FOR ANALYSIS. IF THE DEVICE HAS BEEN SHIPPED, PLEASE PROVIDE THE SHIPMENT TRACKING DETAILS. WE REGULARLY CONTACT WITH SALES REP ABOUT THE DEVICE RETURNING. NO FURTHER INFORMATION WILL BE PROVIDED. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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. THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. TRADE NAME -IRGACARE, ACTIVE INGREDIENT(S)- TRICLOSAN, DOSAGE FORM - SUTURE/SOLID/PARENTERAL, STRENGTH - = 2360 G /M.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 02/24/2022. 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 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. H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION OF THE SAMPLE RETURNED. VISUAL ANALYSIS OF THE RETURNED PRODUCT REVEALED THAT ONE OPENED SAMPLE PRODUCT CODE SXPP1A301 WAS RECEIVED FOR EVALUATION. UPON VISUAL INSPECTION OF THE RETURNED SAMPLE, THE SUTURE BARBS WERE TO BE DAMAGED AT THE TIPS, IN ADDITION THE FIXATION TAB WAS OBSERVED TO HAVE TWO SIDES BROKEN. AFTER FURTHER EVALUATION OF THE FIXATION TAB CRIMPING MARKS WERE OBSERVED ON THE TAB POSSIBLY FROM A SURGICAL DEVICE. IT SHOULD BE NOTED THAT A 100% INSPECTION IS PERFORM VIA AUTOMOTIVE VISION SYSTEM TO ENSURE THE TAB IS PRESENT AND COMPLETE DURING MANUFACTURING. AS WITH ANY DEVICE, CARE SHOULD BE TAKEN TO AVOID DAMAGE TO THE STRAND WHEN HANDLING. AVOID THE CRUSHING OR CRIMPING ACTION OF THE SURGICAL INSTRUMENTS, SUCH AS NEEDLE HOLDERS AND FORCEPS. TO SEAT THE FIXATION TAB; PULL THE DEVICE THROUGH THE TISSUE TO GENTLY SEAT THE FIXATION TAB AGAINST THE TISSUE. THE FIXATION TAB SHOULD BE SEATED ABOVE THE TISSUE PLANE AND BE VISIBLE. DO NOT EXERT ADDITIONAL FORCE ON THE FIXATION TAB. THE MANUFACTURING RECORDS COULD NOT BE REVIEWED AS THE BATCH NUMBER IS UNKNOWN. TRADE NAME - IRGACARE. ACTIVE INGREDIENT(S)- TRICLOSAN. DOSAGE FORM - SUTURE/SOLID/PARENTERAL. STRENGTH -= 2360 G /M.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AND UNKNOWN AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, HE FIXATION TAB WAS BROKEN DURING USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1997652 SFX SYM PDS+ UNI VIO 18IN 1 S/A CTB-1 SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. SXPP1A301 10705031227712

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown