BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHARPOINT

    MDR report key: 2089793 · Received April 12, 2011

    Report

    Report Number
    2522801-2011-00007
    Event Type
    Other
    Date Received
    April 12, 2011
    Date of Event
    March 22, 2011
    Report Date
    April 12, 2011
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    GAR
    PMA / PMN Number
    K903029
    Removal / Correction Number
    PENDING
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE NOT RETURNED TO ANGIOTECH FOR EVALUATION. METHOD: THE DEVICES WERE NOT RETURNED FOR EVALUATION. RESULTS/CONCLUSION: THE DEVICES WERE NOT RETURNED FOR EVAL. MIXED PRODUCT CONFIRMED. NO EVAL IS NECESSARY. (B)(4).

    Description of Event or Problem · 1

    DATE OF EVENT IS ESTIMATED. A REPRESENTATIVE OF CRITICAL ASSIST (DISTRIBUTOR) REPORTED THAT A CUSTOMER OPENED A BOX AND PACKAGES OF (B)(4) (4-0 BLACK MONOFILAMENT NYLON W/DS24 NEEDLE) DEVICES AND FOUND DEVICES WITH A 4-0 BLACK BRAIDED SILK SUTURE WITH A SMALLER NEEDLE ATTACHED INSIDE THE PACKAGES. THE PRODUCT WAS NOT USED ON A PT. NO SAMPLES WERE RETURNED. HOWEVER, FOLLOWING RECEIPT OF THE COMPLAINT, THE INVESTIGATION REVEALED AND CONFORMED THAT PRODUCT FROM TWO (2) SEPARATE ATTACHED LOTS, IN PROCESS AT THE SAME TIME, WERE MISTAKENLY MIXED AND LATER IDENTIFIED. A MATERIAL REPORT WAS ISSUED AND THE TWO (2) LOTS WERE 100% SCANNED FOR MIXED PRODUCT. HOWEVER, A DISCREPANCY IN PIECE COUNTS CONFIRMED THAT PIECES FROM THE SILK LOT WERE NOT POSITIVELY IDENTIFIED AND SEGREGATED FROM THE NYLON LOT. THESE PIECES WERE MISLABELED AND HAVE BEEN IDENTIFIED IN THE FIELD. ADDITIONAL PRODUCT IS AFFECTED. A FIELD CORRECTIVE ACTION (FCA) WAS INITIATED ON (B)(4) 2011 FOR ITEM (B)(4), LOT M446840.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHARPOINT SUTURE WITH NEEDLE GAR SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH) AC-0584D M446840

    Patients

    Seq Age Sex Outcome Treatment
    1