BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL+ UD 27IN 4-0 S/A SH-1

    MDR report key: 13446434 · Received February 3, 2022

    Report

    Report Number
    2210968-2022-00832
    Event Type
    Malfunction
    Date Received
    February 3, 2022
    Date of Event
    January 1, 2022
    Report Date
    March 7, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031051706
    PMA / PMN Number
    K132580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT NUMBER: (B)(4). UPON VISUAL INSPECTION OF THE IMAGE SUBMITTED FOR EVALUATION, A BROKEN NEEDLE OF PRODUCT CODE VCP218H WAS OBSERVED. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS FOR THIS LOT SERIAL NUMBER WERE REVIEWED AND MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS LOT. NO CONCLUSION COULD BE REACHED AS TO THE CAUSE OF THE REPORTED COMPLAINT AS THE SAMPLE WAS NOT RETURNED FOR ANALYSIS. AS PART OF ETHICON'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING OF COMPLAINT INFORMATION FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDS AS PART OF POST-MARKET SURVEILLANCE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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: WERE ALL NEEDLE FRAGMENTS SUCCESSFULLY REMOVED FROM THE PATIENT DURING THIS SINGLE PROCEDURE? HOW WAS IT DETERMINED THAT THE NEEDLE FRAGMENTS WERE REMOVED ENTIRELY (EX. X-RAY, CT, ETC)? WERE THERE ANY PATIENT CONSEQUENCES AS A RESULT OF THIS QUALITY ISSUE? 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: 275 G /M.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> (B)(4) DATE SENT TO THE FDA: 03/07/2022 H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED 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. PHOTO ANALYSIS: UPON VISUAL INSPECTION OF THE IMAGE SUBMITTED FOR EVALUATION, A BROKEN NEEDLE OF PRODUCT CODE VCP218H WAS OBSERVED. TO PREVENT THIS TYPE OF DAMAGE: HOLD THE NEEDLE IN AN AREA ONE-THIRD (1/3) TO ONE-HALF (1/2) THE DISTANCE FROM THE END OF THE ACCESSORY TO THE TIP. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS FOR THIS LOT SERIAL NUMBER WERE REVIEWED AND MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS LOT. NO CONCLUSION COULD BE REACHED AS TO THE CAUSE OF THE REPORTED COMPLAINT AS THE SAMPLE WAS NOT RETURNED FOR ANALYSIS. AS PART OF QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED AND RELEASED TO APPROVED SPECIFICATIONS. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WERE ALL NEEDLE FRAGMENTS SUCCESSFULLY REMOVED FROM THE PATIENT DURING THIS SINGLE PROCEDURE? HOW WAS IT DETERMINED THAT THE NEEDLE FRAGMENTS WERE REMOVED ENTIRELY (EX. X-RAY, CT, ETC)? WERE THERE ANY PATIENT CONSEQUENCES AS A RESULT OF THIS QUALITY ISSUE? -------------------- ALL ANSWERS ABOVE ARE UNOBTAINABLE. ONCE THERE IS ANY UPDATE, WE WILL UPDATE THE INFORMATION. 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 SKIN TUMOR REMOVAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING USE ON THE PATIENT IT WAS NOTED THAT THE NEEDLE BROKE SUDDENLY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452238 VCL+ UD 27IN 4-0 S/A SH-1 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. VCP218H RD2AER 10705031051706

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female