BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE BLU 75CM 2-0 ST-70(2)

    MDR report key: 11125779 · Received January 6, 2021

    Report

    Report Number
    2210968-2021-00097
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Report Date
    December 16, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO FDA: 02/01/2021. H3: ANALYSIS SUMMARY: VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT ONE OPENED SAMPLE DOUBLE-ARMED OF PRODUCT CODE W8400 WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF ONE OPENED SAMPLE THE SWAGE, AND THE ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. NO NEEDLE BREAKAGE WAS OBSERVED ON THE BODY, TIP, OR SWAGE AREA. HOWEVER, THE NEEDLES ARE STRAIGHT AND WERE NOTED BENDING AT THE MIDDLE NEEDLES. THE CONDITION OF THE SAMPLE RECEIVED INDICATES IMPROPER HANDLING OF THE DEVICE SINCE THE NEEDLES WERE NOTED BENDING. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER: PEH596/ W840019, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. 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 Manufacturer Narrative · 1

    (B)(4). (B)(4). ATTEMPTS ARE BEING 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN TAKING OUT THE NEEDLE-SUTURE FROM THE PACKAGE, IT WAS FOUND THAT THE NEEDLE HAD BEEN BROKEN BEFORE USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20144 PROLENE BLU 75CM 2-0 ST-70(2) SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. PEH596

    Patients

    Seq Age Sex Outcome Treatment
    1