BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN

    MDR report key: 2211965 · Received August 10, 2011

    Report

    Report Number
    2522801-2011-00015
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    December 16, 2010
    Report Date
    August 9, 2011
    Manufacturer
    SURGICAL SPECIALTIES CORP (DBA ANGIOTECH)
    Product Code
    GAL
    PMA / PMN Number
    K896554
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED TO THE DISTRIBUTOR OR TO ANGIOTECH FOR EVALUATION. THEREFORE, NO TESTING CAN BE PERFORMED. METHOD: THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED. RESULTS/CONCLUSION: THE DEVICES WERE NOT RETURNED TO THE DISTRIBUTOR OR TO ANGIOTECH FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO CORRESPONDING ISSUES IDENTIFIED DURING THE MANUFACTURING PROCESSES OR AT FINAL INSPECTION. TO DATE, NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THE REPORTED FINISHED GOOD LOT. A DEFINITIVE ROOT CAUSE FOR THE NEEDLES BREAKING DURING PROCEDURES CANNOT BE DETERMINED WITH CERTAINTY. (B)(4).

    Description of Event or Problem · 1

    THE DISTRIBUTOR RECEIVED THIS REPORT ON (B)(6) 2010 AND FORWARDED THE DETAILS TO ANGIOTECH ON 07/21/2011. A CUSTOMER OF THIS DISTRIBUTOR EXPERIENCED NEEDLES BREAKING DURING DENTAL/ORAL PROCEDURES WITH TWO (2) SEPARATE PTS. BOTH NEEDLES WERE RETRIEVED WITH NO ASSOCIATED PT INJURY. HOWEVER, POTENTIAL FOR INJURY EXISTS IF A NEEDLE WERE TO ENTER A PTS AIRWAY AS A RESULT OF SUCH A BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HENRY SCHEIN SUTURE/NEEDLE GAL SURGICAL SPECIALTIES CORP (DBA ANGIOTECH) 101-8824 M362820

    Patients

    Seq Age Sex Outcome Treatment
    1 Other