BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDSII VIO 27IN 3-0 S/A FS-1

    MDR report key: 16593119 · Received March 22, 2023

    Report

    Report Number
    2210968-2023-01926
    Event Type
    Malfunction
    Date Received
    March 22, 2023
    Date of Event
    April 7, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031218703
    PMA / PMN Number
    N18331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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 WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: COULD YOU PLEASE CLARIFY HOW MANY DEVICES PRESENT THIS ISSUE FOR EACH PRODUCT CODE Z452G & Z824G? COULD YOU PLEASE CLARIFY IF THIS WAS A MIX PRODUCT ISSUE? COULD YOU PLEASE PROVIDE MORE INFORMATION. HE CLINIC PURCHASED 1X SUT PDS II 3-0 SA FS-1 27" 12CT (Z452G) WHEN THEY OPENED IT THERE WERE 10 SLEEVES OF Z452G AND 2 SLEEVES OF Z824G (SUT PDS II 3-0 SA PC-5 18" 12CT) WHICH THEY DID NOT PURCHASE. THERE WAS A MIXTURE OF TWO DIFFERENT TYPES OF SUTURE IN THE ONE BOX THEY PURCHASED. I DO NOT BELIEVE THE BOX IS STILL AVAILABLE FOR RETURN. TO DATE IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BOX OF 12 SUTURES HAS 10 CORRECT PACKS OF SUTURE AND 2 INCORRECT PACKS INSIDE OF THE BOX. (ORDERED Z452G BOX 12. BOX HAS 10 PACKS OF Z452G AND 2 PACKS Z824G). THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076618 PDSII VIO 27IN 3-0 S/A FS-1 SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. Z452G RLMJDX 10705031218703

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown