BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEV GN BR 0 TC-43/HR26 2N 36"

    MDR report key: 13334258 · Received January 24, 2022

    Report

    Report Number
    3004365956-2022-00006
    Event Type
    Injury
    Date Received
    January 24, 2022
    Date of Event
    December 17, 2021
    Report Date
    January 17, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAT
    UDI-DI
    14026704603876
    PMA / PMN Number
    K021019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A VISUAL, DIMENSIONAL, FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. A DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE TO THE LACK OF THE BATCH NUMBER TO PERFORM A PROPER INVESTIGATION AND DETERMINE A ROOT CAUSE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 0

    QN#(B)(4). SAMPLE OF BATCH NUMBER 74G1802569 PRODUCT CODE 833-114 WAS RECEIVED WITHOUT THE ORIGINAL PACKAGING AND WAS RECEIVED ON SEALED PLASTIC ZIPLOCK BAG WITH A DISINFECTED IDENTIFICATION. PRODUCT CODE CONFIGURATION IS NEEDLE 2N (2 NEEDLES) - 36" (SUTURE LENGTH). INSIDE OF THE ZIPLOCK PLASTIC BAG RECEIVED 1 EA OF PRODUCT CODE 833-114 BATCH NUMBER 74G1802569, THE SUTURE HAS A LENGTH OF 36 INCH AND WAS RECEIVED WITH 1 NEEDLE AND 1 BULLET ATTACHED AT EVERY END. NO DAMAGE ON THE NEEDLES WAS DETECTED. NEVERTHELESS, THE SUTURES SHOW SIGNS OF MANIPULATION AND CONTAMINATION WAS DETECTED THROUGHOUT THE SUTURE. PRODUCT CODE CONFIGURATION IS NEEDLE 2N (2 NEEDLES) - 36" (SUTURE LENGTH). THE SUTURE HAS A LENGTH OF 36 INCH AND WAS RECEIVED WITH 1 NEEDLE AND 1 BULLET ATTACHED AT EVERY END. NO DAMAGE ON THE NEEDLES WAS DETECTED. CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE TO THE LACK OF DETAIL BY THE COSTUMER. IN ADDITIONAL, BASED ON THE RESULTS OF THE VISUAL INSPECTION THE CONDITION OF CONTAMINATION OBSERVE IN THE SAMPLE CANNOT BE GENERATE AT THE MANUFACTURING PROCESS. MANUFACTURING PERSONNEL WILL BE NOTIFIED OF THIS EVENT FOR AWARENESS.

    Additional Manufacturer Narrative · 0

    (B)(4). DEVICE HISTORY RECORD OF BATCH NUMBER 74G1802569 HAS BEEN REVIEWED. NONCONFORMANCE'S WERE ISSUED FOR ANOTHER CONDITION THAT IS NOT RELATED TO THE FAILURE MODE REPORTED. NO CORRECTIVE ACTION CAN BE IMPLEMENTED DUE TO THE LACK OF PRODUCT CODE TO PERFORM A PROPER INVESTIGATION TO DETERMINE A ROOT CAUSE. CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFORMATION PROVIDED, TO PERFORM AN INVESTIGATION AND DETERMINE THE SOURCE OF DEFECT REPORTED IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED ON THIS COMPLAINT. AN ATTEMPT TO DUPLICATE THE FAILURE MODE WAS MADE BUT AT THE TIME THERE IS NO INVENTORY OF THE INVOLVED PRODUCT CODE AVAILABLE AT THE FACILITY NOR IS BEING MANUFACTURED AT THE TIME.

    Description of Event or Problem · 0

    I WOULD LIKE TO REPORT A NON-CONFORMITY RELATED TO THE CAPIO SUTURE THREAD (B)(4). UPDATE: THE SURGEONS DESCRIBED IN THEIR REPORT, AS FOLLOWS: SINCE THE DISCONTINUATION OF THE SUPPLY OF ABSORBABLE SUTURE THREAD, WHERE WE USED SACROSPINOUS FIXATION FOR COLPUS WE HAVE HAD POSTOPERATIVE COMPLICATIONS DUE TO THE FACT THAT THE THREAD IS NON-ABSORBABLE WE HAVE HAD IMPORTANT GRANULOMAS AT THE SITE, INFECTIOUS PROCESSES AT THE SITE DUE TO THE FOREIGN BODY IN THE VAGINA AND NEED FOR REHOSPITALIZATION UNDERGOING SPINAL ANESTHESIA TO ATTEMPT TO REMOVE THE WIRE, WHICH GENERATES RISK TO THE PATIENT AND COSTS TO THE HOSPITAL.

    Description of Event or Problem · 0

    I WOULD LIKE TO REPORT A NON-CONFORMITY RELATED TO THE CAPIO SUTURE THREAD (REF: (B)(4)). UPDATE: THE SURGEONS DESCRIBED IN THEIR REPORT, AS FOLLOWS: SINCE THE DISCONTINUATION OF THE SUPPLY OF ABSORBABLE SUTURE THREAD, WHERE WE USED SACROSPINOUS FIXATION FOR COLPUS WE HAVE HAD POSTOPERATIVE COMPLICATIONS DUE TO THE FACT THAT THE THREAD IS NON-ABSORBABLE WE HAVE HAD IMPORTANT GRANULOMAS AT THE SITE, INFECTIOUS PROCESSES AT THE SITE DUE TO THE FOREIGN BODY IN THE VAGINA AND NEED FOR REHOSPITALIZATION UNDERGOING SPINAL ANESTHESIA TO ATTEMPT TO REMOVE THE WIRE, WHICH GENERATES RISK TO THE PATIENT AND COSTS TO THE HOSPITAL.

    Description of Event or Problem · 0

    I WOULD LIKE TO REPORT A NON-CONFORMITY RELATED TO THE CAPIO SUTURE THREAD (REF: (B)(4). UPDATE: THE SURGEONS DESCRIBED IN THEIR REPORT, AS FOLLOWS: SINCE THE DISCONTINUATION OF THE SUPPLY OF ABSORBABLE SUTURE THREAD, WHERE WE USED SACROSPINOUS FIXATION FOR COLPUS WE HAVE HAD POSTOPERATIVE COMPLICATIONS DUE TO THE FACT THAT THE THREAD IS NON-ABSORBABLE WE HAVE HAD IMPORTANT GRANULOMAS AT THE SITE, INFECTIOUS PROCESSES AT THE SITE DUE TO THE FOREIGN BODY IN THE VAGINA AND NEED FOR REHOSPITALIZATION UNDERGOING SPINAL ANESTHESIA TO ATTEMPT TO REMOVE THE WIRE, WHICH GENERATES RISK TO THE PATIENT AND COSTS TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1999294 TEV GN BR 0 TC-43/HR26 2N 36" SUTURE, NONABSORBABLE, SYNTHE GAT TELEFLEX MEDICAL IPN000859 74G1802569 14026704603876

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R N/A.| N/A.