BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS II (POLYDIOXANONE) SUTURE

    MDR report key: 1680991 · Received May 5, 2010

    Report

    Report Number
    2210968-2010-00454
    Event Type
    Malfunction
    Date Received
    May 5, 2010
    Date of Event
    April 5, 2010
    Report Date
    April 8, 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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (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 INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH BKM696 MFG DATE: 09/01/2009, EXP DATE: 07/31/2014. BATCH BJZ745 MFG DATE: 08/01/2009, EXP DATE: 07/31/2014. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREATODUODENECTOMY PROCEDURE ON (B)(6) 2010. THE NEEDLE BROKE IN THE MIDDLE OF THE BODY DURING KNOTTED SUTURING AT THE BILE DUCT DURING THE FIRST STITCH. NO FRAGMENT REMAINED IN THE PATIENT'S BODY AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK