BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS II (POLYDIOXANONE) SUTURE

    MDR report key: 1694818 · Received May 17, 2010

    Report

    Report Number
    2210968-2010-00524
    Event Type
    Malfunction
    Date Received
    May 17, 2010
    Date of Event
    February 5, 2010
    Report Date
    April 15, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAK
    PMA / PMN Number
    N18331
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE NEEDLE/SUTURE HAS CRACKED BARREL CONDITION. THE NEEDLE HAS NORMAL SWAGE. NO SUTURE DEFECTS WERE OBSERVED. IN ADDITION, THERE ARE NO MARKS ON THE NEEDLE BY USE OF THE NEEDLE HOLDER. CONCLUSION: THE ACTUAL DEVICE WAS RECEIVED IN A CONDITION WHICH DOES NOT MEET SPECIFICATION. RESULT: REPRESENTATIVE SAMPLES OF THE PRODUCT WERE TESTED FOR KNOT PULL TENSILE STRENGTH AND THE RESULTS OBTAINED WERE IN CONFORMANCE WITH THE REQUIREMENTS. CONCLUSION: NO DEVICE FAILURE DETECTED AND THE PRODUCT IS WITHIN SPECIFICATION. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2010-00525 AND MEDWATCH 2210968-2010-00526. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN EMERGENCY ILEUS SURGICAL PROCEDURE ON (B)(6) 2010. THE SURGEON OPENED THE DEVICE PACKAGING WHICH HE REPORTED APPEARED NORMAL, BUT THE SURGEON DID NOT USE THE DEVICE ON THE PATIENT. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PDS II (POLYDIOXANONE) SUTURE SUTURE, ABSORBABLE GAK ETHICON, INC. NA BAZ549

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK