BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRLNE BLU 30IN 7-0 D/A BV-1 EP

    MDR report key: 16755971 · Received April 17, 2023

    Report

    Report Number
    2210968-2023-02755
    Event Type
    Malfunction
    Date Received
    April 17, 2023
    Date of Event
    April 4, 2023
    Report Date
    May 17, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031206830
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: PLEASE CONFIRM HOW MANY SUTURES BROKE "AFTER REMOVAL FROM PACKAGE (BEFORE USE ON THE PATIENT)" AND HOW MANY "AFTER THE FIRST STITCH (DURING USE ON THE PATIENT)" DURING THIS ONE PROCEDURE? NO EXACT INFO IS AVAILABLE, AS NO STITCH LIST WAS KEPT. HOWEVER, THERE TENDED TO BE MORE THREADS BUSY AFTER THE FIRST STITCH. PROCEDURE NAME AND DATE? DATE (B)(6) 2023 VASCULAR PROSTHESIS PELVIS/KNEE. PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS (NOT THE PERSON RELAYING/SUBMITTING ANSWERS TO LOC OR CHU) DR. (B)(6) (PLEASE ALWAYS ONLY IN CONSULTATION WITH SALES REP) AFFECTED PRODUCTS: EP8703H, LOT SBBALX 10 EA INVOLVED 4 EA WILL RETURN. EP8703H, LOT SMBBLQ 2 EA INVOLVED 23 EA WILL RETURN. EVENT DAY (B)(6) 2023. PROCEDURE FINISHED WITH SAME LIKE PRODUCT. EVENTS REPORTED VIA: 2210968-2023-02751, 2210968-2023-02754, 2210968-2023-02755, 2210968-2023-02756, 2210968-2023-02760, 2210968-2023-02761, 2210968-2023-02762, 2210968-2023-02763, AND 2210968-2023-02764.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 5/17/2023 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 NO DEVICE PROBLEM FOUND ADDITIONAL INFORMATION: D9, H3, H6 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3 INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TEST EVALUATION WERE CONDUCTED ON THE RETURNED DEVICE. THE RETURNED SAMPLE REVEALED THAT ONE OPENED BOX WITH FOUR PACKETS THAT PERTAIN TO PRODUCT CODE EP8703H WAS RETURNED FOR ANALYSIS. UPON INITIAL INSPECTION, OF THE SAMPLES, NO EXTERNAL DAMAGES WERE OBSERVED ON THE PACKETS. IN ORDER TO EVALUATE THE CONDITION OF THE RETURNED SAMPLES, THE PACKETS WERE OPENED. THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG OF THE STRAND TO DETECT ANY ISSUE RELATED TO DAMAGED OR BREAKAGE SUTURES AND NO DEFECTS WERE OBSERVED DURING EVALUATION. A FUNCTIONAL TEST WAS PERFORMED, AND THE TENSILE STRENGTH RESULTS WERE ABOVE THE MINIMUM REQUIREMENTS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DEFECT NOTED. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH BATCH IS RANDOMLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. RELATED REPORTS: 2210968-2023-02751, 2210968-2023-02754, 2210968-2023-02755, 2210968-2023-02756, 2210968-2023-02760, 2210968-2023-02761, 2210968-2023-02762, 2210968-2023-02763, 2210968-2023-02764, & 2210968-2023-02766.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROSTHESIS PELVIS/KNEE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER COMPLAIN THAT THE THREADS SPLIT OPEN SIMILAR TO HAIR AND THEREBY OFTEN BREAK DIRECTLY AFTER THE FIRST STITCH. PROCEDURE FINISHED WITH SAME LIKE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2321824 PRLNE BLU 30IN 7-0 D/A BV-1 EP SUTURE, NONABSORBABLE, SYNTHETIC GAW ETHICON INC. EP8703H SBBALX 10705031206830

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown