BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS PLUS ANTIBACTERIAL (POLYDIOXANONE) SUTURE

    MDR report key: 3833471 · Received May 27, 2014

    Report

    Report Number
    2210968-2014-06692
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 9, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    K061037
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    CONCLUSION: A NEEDLE THAT BROKE IN THE BODY WAS SUBMITTED FOR THIS EVALUATION. A MICROSCOPIC INSPECTION FOUND THAT THE NEEDLE EXHIBITED AMOUNTS OF INTERGRANULAR AND POSSIBLY SOME TRANSGRANULAR FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT CORONARY ARTERY BYPASS ON (B)(6) 2014 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE WHILE MAKING A KNOTTED SUTURE THROUGH THE PATIENT'S DERMA. THE NEEDLE PIECE WAS RETRIEVED. THERE WAS NO ADVERSE PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310969 PDS PLUS ANTIBACTERIAL (POLYDIOXANONE) SUTURE SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. UNK HAK562

    Patients

    Seq Age Sex Outcome Treatment
    1