BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS CORD

    MDR report key: 3243162 · Received July 23, 2013

    Report

    Report Number
    2210968-2013-14221
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 5, 2013
    Report Date
    July 8, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    (B)(4): THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE ACTUAL SAMPLE (DOUBLE ARMED) SHOWS A DISPENSED CORD WITH ONE ATTACHED NEEDLE AND ONE DETACHED CORD END WITH LOOSE NEEDLE. THE VISUAL INSPECTION UNDER A LIGHT-MICROSCOPE SHOWS AN INCORRECT ATTACHMENT MARK AT THE CORD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED. ONE NEEDLE WAS NOT ATTACHED TO THE SUTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342378 PDS CORD SUTURES - ABSORBABLE NEW ETHICON INC. UNK DB8HJRC0

    Patients

    Seq Age Sex Outcome Treatment
    1