BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL+ UD 18IN 5-0 S/A PS-3 PRM MP

    MDR report key: 16383757 · Received February 15, 2023

    Report

    Report Number
    2210968-2023-01151
    Event Type
    Malfunction
    Date Received
    February 15, 2023
    Date of Event
    February 1, 2023
    Report Date
    May 30, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031053861
    PMA / PMN Number
    K032420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 2/3/2023. 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 WAS REQUESTED, THE FOLLOWING WAS OBTAINED: PLEASE CLARIFY HOW MANY NEEDLES SEPARATED DURING 5-10 MIN DELAY IN SURGERY? PHYSICIAN FOUND ALL 36 EA SUTURE ARE PULL OFF FROM NEEDLE. IT IS NOT CLEAR HOW 36 NEEDLES COULD SEPARATE FROM THE SUTURE DURING A SHORT TIME PERIOD OF 5-10 MIN? -PLEASE EXPLAIN. THE OPERATION WAS DELAYED BUT TIME OF DELAY PERIOD IS NOT AVAILABLE. NO CONSEQUENCES WITH PATIENT FROM THE DELAYED OPERATION DID 36 NEEDLES TOUCH THE PATIENT? ALL THE SUTURE TOUCHED PATIENT IT WAS REPORTED THAT ZERO SUTURES ARE BEING RETURNED. HOW MANY NEEDLES WERE USED DURING SURGERY ON (B)(6) 2023? HOW MANY NEEDLES SEPARATED WHILE USING IN THE PATIENT¿S TISSUE ON (B)(6) 2023? -36. IS THE EXACT NUMBER OF NEEDLES THAT SEPARATED WHILE THE SURGEON WAS USING UNKNOWN? 36. DID SOME NEEDLES SEPARATE BEFORE THEY TOUCHED THE PATIENT? NO. WERE SOME SUTURES TESTED AFTER THE PROCEDURE? NO. RELATED REPORTS: 2210968-2023-01564, 2210968-2023-01565, 2210968-2023-01566, 2210968-2023-01567, 2210968-2023-01568, 2210968-2023-01569, 2210968-2023-01570, 2210968-2023-01571, 2210968-2023-01572, 2210968-2023-01573, 2210968-2023-01574, 2210968-2023-01575, 2210968-2023-01576, 2210968-2023-01577, 2210968-2023-01578, 2210968-2023-01579, 2210968-2023-01151, 2210968-2023-01150, 2210968-2023-01580, 2210968-2023-01581, 2210968-2023-01582, 2210968-2023-01583, 2210968-2023-01584, 2210968-2023-01585, 2210968-2023-01589, 2210968-2023-01591, 2210968-2023-01592, 2210968-2023-01593, 2210968-2023-01594, 2210968-2023-01595, 2210968-2023-01596, 2210968-2023-01597, 2210968-2023-01598, 2210968-2023-01600, 2210968-2023-01601, 2210968-2023-01602.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 5/30/2023. 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 PROBLEM FOUND. H3 INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TEST EVALUATION WERE CONDUCTED ON THE RETURNED DEVICES. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THREE SEALED BOXES WITH THIRTY-SIX PACKETS EACH THAT PERTAIN TO PRODUCT CODE VCP500H WERE RECEIVED FOR EVALUATION. UPON INITIAL INSPECTION, OF THE SAMPLES, NO EXTERNAL DAMAGES WERE OBSERVED ON THE PACKETS. AS PER THE SAMPLING PLAN, A VISUAL INSPECTION WAS PERFORMED ON THIRTY-TWO SAMPLES, THE PACKETS WERE OPENED, AND THE SWAGE AND ATTACHMENT AREA WAS NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG THE STRAND NO ANOMALIES WERE OBSERVED DURING THE EVALUATION. A FUNCTIONAL TEST WAS PERFORMED USING INSTRON EQUIPMENT AND THE PULL FORCE RESULT WAS ABOVE THE MINIMUM REQUIREMENTS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DEFECT NOTED. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. RELATED REPORTS: 2210968-2023-01564, 2210968-2023-01565, 2210968-2023-01566, 2210968-2023-01567, 2210968-2023-01568, 2210968-2023-01569, 2210968-2023-01570, 2210968-2023-01571, 2210968-2023-01572, 2210968-2023-01573, 2210968-2023-01574, 2210968-2023-01575, 2210968-2023-01576, 2210968-2023-01577, 2210968-2023-01578, 2210968-2023-01579, 2210968-2023-01150, 2210968-2023-01580, 2210968-2023-01581, 2210968-2023-01582, 2210968-2023-01583, 2210968-2023-01584, 2210968-2023-01585, 2210968-2023-01589, 2210968-2023-01591, 2210968-2023-01592, 2210968-2023-01593, 2210968-2023-01594, 2210968-2023-01595, 2210968-2023-01596, 2210968-2023-01597, 2210968-2023-01598, 2210968-2023-01600, 2210968-2023-01601, 2210968-2023-01602.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. 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. WAS THERE ANY CHANGE IN THE PATIENT¿S POST-OPERATIVE CARE DUE TO THE PROLONGED PROCEDURE? WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE PROLONGED SURGERY TIME? COULD YOU PLEASE CLARIFY IF THE PATIENT SUFFERED FROM ANY SIGNS OR CONSEQUENCES DUE TO THE ISSUE? PLEASE PROVIDE MORE INFORMATION. COULD YOU PLEASE CLARIFY HOW MANY SUTURES GOT SEPARATED FROM THE NEEDLE? A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. TRADE NAME - IRGACARE®, ACTIVE INGREDIENT(S) ¿ TRICLOSAN, DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL, AND STRENGTH ¿ = 275 G/M. EVENTS REPORTED VIA: 2210968-2023-01150.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 3/3/2023. 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 WAS REQUESTED, THE FOLLOWING WAS OBTAINED: -EVENT DATE : 1 FEB 2023. -PRODUCT TO BE RETURNED: 36 EA. -WAS THERE ANY CHANGE IN THE PATIENT¿S POST-OPERATIVE CARE DUE TO THE PROLONGED PROCEDURE? NO. -WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE PROLONGED SURGERY TIME? NO - COULD YOU PLEASE CLARIFY IF THE PATIENT SUFFERED FROM ANY SIGNS OR CONSEQUENCES DUE TO THE ISSUE? PLEASE PROVIDE MORE INFORMATION? NO -COULD YOU PLEASE CLARIFY HOW MANY SUTURES GOT SEPARATED FROM THE NEEDLE? EVERY PIECE 36 EA/36EA. -DID 36 NEEDLES PULL OFF FROM SUTURE DURING USE DURING THIS ONE PATIENT BREAST SURGERY ON 2/1/2023? : 1 PATIENT -DID 36 NEEDLES PULL OFF FROM SUTURE (WHILE IN THE PACKAGE / DURING DISPENSING / DURING PREPARATION / DURING USE)? : DURING USE -HOW MANY NEEDLES PULL OFF FROM SUTURE DURING USE? 36 EA OR -ARE 36 UNOPENED SUTURES BEING RETURNED? : 3 ATTEMPTS FOLLOW UP, NO PRODUCT RETURN RESPONSE. THE FOLLOWING ADDITIONAL INFORMATION WAS REQUESTED: PLEASE CLARIFY HOW MANY NEEDLES SEPARATED DURING 5-10 MIN DELAY IN SURGERY? IT IS NOT CLEAR HOW 36 NEEDLES COULD SEPARATE FROM THE SUTURE DURING A SHORT TIME PERIOD OF 5-10 MIN? PLEASE EXPLAIN. DID 36 NEEDLES TOUCH THE PATIENT? IT WAS REPORTED THAT ZERO SUTURES ARE BEING RETURNED. HOW MANY NEEDLES WERE USED DURING SURGERY ON 2/1/2023? HOW MANY NEEDLES SEPARATED WHILE USING IN THE PATIENT¿S TISSUE ON 2/1/2023? IS THE EXACT NUMBER OF NEEDLES THAT SEPARATED WHILE THE SURGEON WAS USING UNKNOWN? DID SOME NEEDLES SEPARATE BEFORE THEY TOUCHED THE PATIENT? WERE SOME SUTURES TESTED AFTER THE PROCEDURE? PRODUCT COMPLAINT # PC-001285658 DATE SENT TO THE FDA: 3/3/2023. CORRECTED INFORMATION: B3. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE SEPARATE WITH SUTURES DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557482 VCL+ UD 18IN 5-0 S/A PS-3 PRM MP SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. VCP500H SCMDMK 10705031053861

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown