BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN

    MDR report key: 6991214 · Received October 31, 2017

    Report

    Report Number
    3010692967-2017-00011
    Event Type
    Malfunction
    Date Received
    October 31, 2017
    Date of Event
    March 2, 2017
    Report Date
    March 25, 2017
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION
    Product Code
    GAR
    PMA / PMN Number
    K903029
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    -METHOD: THE ACTUAL PRODUCT INVOLVED WITH THE INCIDENT WAS DISCARDED. NO SAMPLES WERE RETURNED FOR EVALUATION TO DATE. -RESULTS/CONCLUSIONS: NO SAMPLES WERE RETURNED FOR REVIEW. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED. THE PRODUCT FROM THIS FINISHED GOOD LOT AND ALL OF THE COMPONENT LOTS MET CURRENT (B)(4). REQUIREMENTS THROUGHOUT THE INCOMING, MANUFACTURING AND THE FINAL INSPECTION PROCESSES. NO INVENTORY IS AVAILABLE FOR THE FINISHED GOOD LOT REPORTED. -WITHOUT RECEIVING SAMPLES TO REVIEW/TEST, RECEIVING DETAILED INFORMATION REGARDING THE PRE-OPERATIVE PREPARATION OF THE DEVICE OR THE SURGEON'S TECHNIQUE, A DEFINITIVE ROOT CAUSE FOR THE NEEDLE BREAKING DURING USE CANNOT BE DETERMINED AT THIS TIME. REFERENCE:REFERENCE (B)(4). - HENRY SCHEIN REFERENCE #(B)(4) - ITEM #900-7482 HENRY SCHEIN HS C1 6-0 BK MN NYL 18"/45CM , LOT MBPA220.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE BROKE WHILE CLOSING LACERATION ON THE CHIN OF TWO (2) PEDIATRIC PATIENTS. AN XRAY WAS REQUIRED TO LOCATE THE NEEDLE SEGMENT RETAINED IN THE WOUND. THE SUTURE OF ONE (1) PATIENT HAD TO BE PARTIALLY BACKED OUT TO RETRIEVE THE BROKEN PIECE. THE PIECES WERE REMOVED WITHOUT INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771846 HENRY SCHEIN HS C1 6-0 BK MN NYL 18"/45CM GAR SURGICAL SPECIALTIES CORPORATION 900-7482 MBPA220

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention