BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS PLUS VIO 8X18IN(45CM) USP4-0(M1.5) S/A RB-1 CR

    MDR report key: 23888898 · Received December 24, 2025

    Report

    Report Number
    2210968-2025-14577
    Event Type
    Malfunction
    Date Received
    December 24, 2025
    Report Date
    December 24, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031218758
    PMA / PMN Number
    K061037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 2/18/2026 THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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 INFORMATION: H6 D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN, THE FULL UDI IS CURRENTLY NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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. 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: WAS THE NEEDLE PIECE(S) RETRIEVED DURING THE SAME PROCEDURE? UNK. COULD YOU PLEASE CONFIRM THE LOT NUMBER? 831528. DO YOU HAVE ANY PHOTOS OF THE NEEDLE AVAILABLE FOR VISUAL ANALYSIS? NO AVE. WAS THERE ANY ADDITIONAL TISSUE DAMAGE RESULTING FROM THE SEARCH FOR THE NEEDLE PIECE?UNK. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE NEEDLE TIP WAS BROKEN. THE NEEDLE TIP WAS LOST BUT FOUND BY X-RAY, AND IT WAS REMOVED. THIS PRODUCT IS IN THE SOT TRAY. IT WAS A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828682 PDS PLUS VIO 8X18IN(45CM) USP4-0(M1.5) S/A RB-1 CR SUTURES - ABSORBABLE NEW ETHICON INC. 831528 10705031218758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown