BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRLNE BLU 30IN 6-0 D/A C-1

    MDR report key: 21719771 · Received March 28, 2025

    Report

    Report Number
    2210968-2025-03246
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Date of Event
    February 28, 2025
    Report Date
    October 30, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031019430
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4 LOT: LOT IS UNKNOWN, 2 POSSIBLE LOTS PROVIDED: 101RX2, 102208 . ADDITIONAL INFORMATION PROVIDED: THEY HAD SEVERAL SUTURES BREAK AS THEY WERE SUTURING. SALES REP SAW TWO OF THEM BREAK. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED. ATTEMPTS TO OBTAIN THE DEVICE HAVE BEEN MADE. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. - HOW MANY DEVICES DEMONSTRATED THE REPORTED ALLEGED DEFICIENCY ("...THEY HAD SEVERAL SUTURES BREAK AS THEY WERE SUTURING...")? - PLEASE CONFIRM THE CORRECT LOT NUMBER (101RX2 OR 102208). - PROVIDE THE SOURCE OR NAME AND TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP). NO PRODUCT IS AVAILABLE FOR RETURN. 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.

    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, 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. CORRECTED D3 MANUFACTURER EMAIL. ADDITIONAL H6 TYPE OF INVESTIGATION. ADDITIONAL INFORMATION: D4, H4 - THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. TWO POSSIBLE BATCH NUMBERS ARE REPORTED AS FOLLOWS: BATCH 101RX2, EXPIRATION DATE: MAY/31/2029, DATE OF MFG.: JUN/22/2024. BATCH 102208. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE POSSIBLE FINISHED DEVICE LOT 101RX2, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    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, 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. CORRECTED DATA: H6, D4. COMPONENT CODE SHOULD BE INSUFFICIENT INFORMATION G07003 AND NOT G07002. D4: FULL UDI CURRENTLY UNAVAILABLE SINCE THE EXACT LOT OF THE SUSPECTED DEVICE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT A CAROTID ENDARTERECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. SUTURE BROKE RIGHT IN THE MIDDLE AS THEY WERE SUTURING. UNKNOWN WHICH LOT NUMBER. NO PATIENT HARM WAS REPORTED. NO PRODUCT WILL BE RETURNED, DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2692001 PRLNE BLU 30IN 6-0 D/A C-1 SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. 10705031019430

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown