BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFX SPI PDS+ UNI VIO 12IN 0 S/A CT-1

    MDR report key: 15414460 · Received September 13, 2022

    Report

    Report Number
    2210968-2022-07456
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    January 28, 2022
    Report Date
    October 6, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031236219
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. 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. 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE DESCRIBE THE STERILE PACKAGING: WERE THERE ANY ISSUES WITH THE SEAL OF THE STERILE PACKAGING? ARE THERE ANY TEARS/HOLES IN THE STERILE PACKAGING? TRADE NAME - IRGACARE®. ACTIVE INGREDIENT(S) ¿ TRICLOSAN. DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL. STRENGTH ¿ = 2360 G/M. EVENTS REPORTED VIA: 2210968-2022-07454, 2210968-2022-07455, AND 2210968-2022-07457.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 10/6/2022 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, 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. H6 COMPONENT CODE: G07002 NO DEVICE RETURNED. H6 COMPONENT CODE: C22 - PHOTO ANALYSIS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: WERE THERE ANY ISSUES WITH THE SEAL OF THE STERILE PACKAGING? ARE THERE ANY TEARS/HOLES IN THE STERILE PACKAGING? -PLEASE REFER TO COMPLAINT DESCRIPTION AND RELATED ATTACHMENTS, THIS IS A PRODUCT COMPLAINT FOR SHIPPING PRODUCTS THAT ARE NOT CONFORMING TO THE LOCAL REGULATION AS PER PRODUCT REGISTRATION FOR MISSING THE STERILIZATION LOGO ON THE 1RY & 2RY PACKS. DEVICE RETURN STATUS? -CURRENTLY PRODUCTS ARE QUARANTINED BY HA, IT DEPENDS ON BUSINESS DECISION IF THEY WILL RE-EXPORT OR DESTRUCT LOCALLY. H3 INVESTIGATIONAL SUMMARY ¿ PHOTO ANALYSIS: THIS IS AN ANALYSIS FOR A PHOTO SUBMITTED TO ETHICON FOR EVALUATION. AN INVESTIGATION WAS CONDUCTED TO COMPARE THE GRAPHICS USED AND THE INVESTIGATION HIGHLIGHTED THAT THE GRAPHICS USED IN EACH BATCH NUMBER ARE CORRECT BASED ON THE DATES OF MANUFACTURE AND THE FINISHED DRAWING. THE GRAPHIC USED IN THE SBBHCT LOT NUMBER IS VERSION 30. BASED ON THE PHOTO REVIEW, THE EVENT DESCRIBE IS NOT CONFIRMED, HOWEVER NO CONCLUSION OR ROOT CAUSE COULD BE DETERMINED. HANDS ON DEVICE ANALYSIS MAY PROVIDE THE ADDITIONAL EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE OF THE REPORTED EVENT. BECAUSE THE INSTRUMENT WAS NOT RETURNED OUR EVALUATION IS LIMITED. AS PART OF ETHICON QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. RELATED REPORTS: 2210968-2022-07454, 2210968-2022-07455, 2210968-2022-07457.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND BARBED SUTURE WAS USED. BEFORE USE ON THE PATIENT, A CONCERN RELATED TO THE PRODUCT QUALITY ISSUE ABOUT THE STERILIZATION LOGO MISSING WAS NOTED DURING INSPECTION ON THE PRODUCTS RECEIVED AT DISTRIBUTOR. THIS IS THE 3RD ITERATION OF SAME CASE (STRATAFIX WITH NO STERILIZATION METHOD CODE ON 1RY/2NDRY PACKAGING);1ST CASE: (STRATAFIX WITH NO STERILIZATION METHOD CODE ON 2NDRY PACKAGING); INITIAL CASE TOOK PLACE ON (B)(6) 2020 AND WAS ESCALATED UNDER PQI ESCALATION ID: (B)(4). 2ND CASE: NON-CE STRATAFIX WITH NO STERILIZATION METHOD CODE AGAINST LOCAL REGISTRATION, TOOK PLACE ON (B)(6) 2021, ESCALATED UNDER PQI (B)(4). NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2391893 SFX SPI PDS+ UNI VIO 12IN 0 S/A CT-1 SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC. SXPP1B450 SBBHCT 10705031236219

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown