BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECULUM TUBING, 10MM, CORRUGATED, WITH CANNULA CONNECTOR

    MDR report key: 18809637 · Received February 29, 2024

    Report

    Report Number
    1721194-2024-00030
    Event Type
    Malfunction
    Date Received
    February 29, 2024
    Date of Event
    January 1, 2024
    Report Date
    April 11, 2024
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    FCZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 2/29/2024. D4 BATCH # UNK. B3: ONLY EVENT YEAR KNOWN: 2024. LOT NUMBER WAS RECEIVED AND DHR IS PENDING REVIEW. WHEN THE REVIEW IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT WITH A SUMMARY OF THE EVALUATION. 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

    (B)(4) DATE SENT: 3/27/2024.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 4/11/2024 INVESTIGATION SUMMARY THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED DEVICES. VISUAL ANALYSIS OF THE 25 RETURNED SAMPLES DETERMINED THAT THE 2395J FILTERS WERE RECEIVED IN THEIR INDIVIDUAL STERILE PACKAGING WITH NO APPARENT DAMAGE. DUE TO THE CARTON BOX WAS NOT RETURNED, WE WERE UNABLE TO FURTHER INVESTIGATE THE REPORTED EVENT. AS PART OF ETHICON ENDO SURGERY¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE FILTER PERFORMED WITHOUT ANY DIFFICULTIES NOTED. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH 211197, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ACCOUNT RECEIVED A REPLACEMENT ITEM WHERE ON THE BOX IT SHOWS EXP 8/2048 BUT ON THE ITEM IT SHOWS EXP 3/2024. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498182 SPECULUM TUBING, 10MM, CORRUGATED, WITH CANNULA CONNECTOR MEGADYNE¿ SPECULUM TUBING FCZ MEGADYNE MEDICAL PRODUCTS, INC. 211197

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown