BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRLNE BLU 24IN 6-0 D/A CC-1 MP

    MDR report key: 18886339 · Received March 12, 2024

    Report

    Report Number
    2210968-2024-02905
    Event Type
    Injury
    Date Received
    March 12, 2024
    Date of Event
    January 18, 2024
    Report Date
    April 29, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> PC-(B)(4) THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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. ADDITIONAL INFORMATION: D4, D9, H3, H6 ADDITIONAL INFORMATION: D4, H4 - THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH TGBKQD MFG DATE: - JUN/29/2023, EXP DATE: MAY/31/2028 BATCH THBDHU MFG DATE: JUL/20/2023, EXP DATE: JUN/30/2028 IN ADDITION, A REVIEW OF THE MANUFACTURING RECORD EVALUATION FOR THE POSSIBLE BATCH NUMBER WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. THE RETURNED PRODUCT DETERMINED THAT IT WAS RECEIVED SEVEN UNOPENED SAMPLES THAT PERTAINED TO THE PRODUCT CODE W8707. A VISUAL INSPECTION WAS PERFORMED ON THE SAMPLES, THE PACKETS WERE EXAMINED FOR VISUAL DEFECTS: APPEARANCE, COLOR PACKAGE, WRINKLES IN THE SEAL AREA, CONTINUOUS SEALS, SEAL MARGINS, OVER-SEALING, DAMAGE (TORN, PUNCTURED) AND NONE WAS OBSERVED. THE PACKETS WERE OPENED, AND THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. DURING THE VISUAL INSPECTION, THE SUTURES WERE CORRECTLY PLACED ON THE WINDING FORMER. THE SUTURES WERE DISPENSED WITHOUT PROBLEM AND EXAMINED ALONG THE STRAND AND NO ANOMALIES OR DAMAGE ON THE SUTURE SURFACE COULD BE OBSERVED. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED EVENT. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. THE RETURNED PRODUCT DETERMINED THAT IT WAS RECEIVED TWO UNOPENED SAMPLES THAT PERTAINED TO THE PRODUCT CODE W8707. A VISUAL INSPECTION WAS PERFORMED ON THE SAMPLES, THE PACKETS WERE EXAMINED FOR VISUAL DEFECTS: APPEARANCE, COLOR PACKAGE, WRINKLES IN THE SEAL AREA, CONTINUOUS SEALS, SEAL MARGINS, OVER-SEALING, DAMAGE (TORN, PUNCTURED) AND NONE WAS OBSERVED. THE PACKETS WERE OPENED, AND THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. DURING THE VISUAL INSPECTION, THE SUTURES WERE CORRECTLY PLACED ON THE WINDING FORMER. THE SUTURES WERE DISPENSED WITHOUT PROBLEM AND EXAMINED ALONG THE STRAND AND NO ANOMALIES OR DAMAGE ON THE SUTURE SURFACE COULD BE OBSERVED. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED EVENT. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED 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. **WERE ALL 12 SUTURES USED IN THIS ONE PATIENT PROCEDURE? **IF NO, PLEASE CLARIFY HOW MANY SUTURES WERE USED AND INCLUDE THE NUMBER OF SUTURES PER PRODUCT CODE FOR THIS PATIENT. PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE DATE AND NAME OF INDEX (INITIAL) SURGICAL PROCEDURE? THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? (OPEN, LAPAROSCOPIC OR OTHER)? ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? HOW WAS THE SUTURE ORIGINALLY TIED (MULTIPLE KNOTS, SQUARE KNOT, ETC.)? WHAT DATE DID THE PATIENT PRESENT WITH SYMPTOMS? WHAT DESCRIBE THE SYMPTOMS THE PATIENT EXPERIENCED FOLLOWING THE INDEX SURGICAL PROCEDURE. PLEASE EXPLAIN "FIBROSIS OF SUTURE". DID THE SUTURE FRAY POST OP? DID THE SUTURE BROKE POST OP? WHAT WAS THE DATE OF THE SECOND PROCEDURE? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? WILL PRODUCT BE RETURNED? IF SO, PLEASE PROVIDE THE RETURN DATE AND TRACKING INFORMATION. RELATED EVENTS REPORTED VIA 2210968-2024-02889, 2210968-2024-02890, 2210968-2024-02891, 2210968-2024-02892, 2210968-2024-02893, 2210968-2024-02894, 2210968-2024-02901, 2210968-2024-02902, 2210968-2024-02903, 2210968-2024-02904, 2210968-2024-02905, 2210968-2024-02906

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. FIBROSIS OF THE SUTURE USED TO MAKE ANASTOMOSIS ON THE AORTA WAS REPORTED. THE PATIENT UNDERWENT REOPERATION. A SEAM OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221434 PRLNE BLU 24IN 6-0 D/A CC-1 MP SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention