BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRLNE BLU 4X30IN 7-0 D/A BV-1

    MDR report key: 23704725 · Received December 3, 2025

    Report

    Report Number
    2210968-2025-13520
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    January 1, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031045781
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 12/3/2025. 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, 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 PENDING EVALUATION OF RETURNED DEVICE ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: I WAS NOT THERE FOR THE SURGERY BUT DURING A SURGERY ON 10/4, THE SURGEON EXPERIENCED THE SUTURES BREAKING DURING HIS SURGERIES FROM THESE TWO CODES. HOW MANY DEVICES DEMONSTRATED THE ALLEGED DEFICIENCY? TO MY KNOWLEDGE, 2 STRANDS OF SUTURES WERE BROKEN. COULD YOU KINDLY PERFORM THE FOLLOW-UP ATTEMPT FOR THE PRODUCT RETURN? PLEASE ENSURE THAT THE SHIPMENT TRACKING NUMBER IS PROVIDED. WAS THERE A RETURN PACKAGE SHIPPED TO THE ACCOUNT? IF NOT, SDT (PLEASE REFER TO THE ATTACHED EMAIL) WILL BE THE PERSON TO RECEIVED THE PACKAGE. PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS: 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, THE FOLLOWING WAS OBTAINED: PRODUCT CODE: (5) M8703. PRODUCT LOT/BATCH: 105M6T. TRACKING#: (B)(4) (IRVINE, CA). RECEIVED AT CG LABS ON 11/25/2025. 1. COULD YOU PLEASE CLARIFY IF EXTRA DEVICE BELONGS TO THIS COMPLAINT? 2. IF NOT, COULD YOU PLEASE CLARIFY IF THE EXTRA RECEIVED PRODUCT BELONGS TO A DIFFERENT COMPLAINT? IF SO, CAN YOU PLEASE PROVIDE THE COMPLAINT NUMBER. 3. IF THE DEVICE WAS NOT REPORTED BEFORE, PLEASE PROVIDE MORE DETAILS OF DEVICE MALFUNCTION. 4. IF THE PRODUCT DOESN¿T BELONG TO ANY COMPLAINT, PLEASE LET US KNOW SO WE CAN DISCARD IT OR ADVISE IF THE PRODUCT IS REQUIRED TO BE RETURNED. THE MULTIPLE SUTURES THAT CONTINUED TO BREAK DURING THE PROCEDURE WERE DISCARDED. THE OR COORDINATOR ALONG WITH MATERIALS MANAGER PULLED BOTH BOXES OFF THE SHELF DUE TO THE INTEGRITY OF THE PRODUCT DURING THE PROCEDURE. I WAS TOLD THAT THE DOCTOR HAS USED THIS PRODUCT FOR MANY YEARS AND NEVER HAS HAD THIS PROBLEM. PER THE SAFETY OF THE PATIENT, THE HOSPITAL STAFF PULLED THE TWO BOXES OF SUTURES AND HAVE RETURNED THEM IN THE PRODUCT COMPLAINT BOX THAT WAS SHIPPED. A DEVICE HAS BEEN RECEIVED, HOWEVER IT HAS NOT YET BEEN EVALUATED. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 12/31/2025. 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, 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. 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 ETH FOR EVALUATION. VISUAL INSPECTION REVELATED THAT FIVE UNOPENED SAMPLES WERE RECEIVED FOR ANALYSIS. PRODUCT CODE M8703. UPON VISUAL INSPECTION OF THE RETURNED SAMPLES, NO EXTERNAL DAMAGES WERE OBSERVED ON THE PACKETS. THE SWAGE AND ATTACHMENT AREA OF THE NEEDLES WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND NO ANOMALIES OR SUTURE BREAKAGE COULD BE OBSERVED. A FUNCTIONAL TEST USING INSTRON EQUIPMENT CONFIRMED THAT THE TENSILE FORCE OF THE SUTURES WAS ABOVE THE MINIMUM REQUIREMENTS. AS PART OF ETH QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE WAS RETURNED WITHOUT DETECTABLE DAMAGE. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED TO THE DL BY THE SALES REP THAT THE 7-0 PROLINE BV-1 MULTIPASS NEEDLE THAT SUTURES KEPT BREAKING DURING SURGERY. THE 5-0 PROLINE C-1 NEEDLE ALSO CONTINUED TO BREAK. THERE WAS NO ADVERSE IMPACT ON PATIENT/USER REPORTED. DEVICES ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2849824 PRLNE BLU 4X30IN 7-0 D/A BV-1 SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. 105M6T 10705031045781

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown