BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL PLUS ANTIBACTERIAL SUTURE

    MDR report key: 1051553 · Received May 16, 2008

    Report

    Report Number
    2210968-2008-00355
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    April 13, 2008
    Report Date
    April 18, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROD UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PROD IS REC'D ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    INTL CUSTOMER REPORTED THAT A NEEDLE BROKE WHILE CLOSING A PORT SITE. THE NEEDLE FRAGMENT WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VICRYL PLUS ANTIBACTERIAL SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA AA8BPKP0

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK