BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN

    MDR report key: 6991470 · Received October 31, 2017

    Report

    Report Number
    3010692967-2017-00012
    Event Type
    Malfunction
    Date Received
    October 31, 2017
    Date of Event
    March 30, 2017
    Report Date
    April 13, 2017
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION
    Product Code
    GAB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 #900-4421 HENRY SCHEIN 3-0 PGA UNDYD BR 18"/45CM PC31 , LOT MBCQ750.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE BROKE DURING A CYST EXCISION ON THE NECK. AN XRAY WAS REQUIRED TO LOCATE THE NEEDLE SEGMENT RETAINED IN THE WOUND. THE PIECE WAS REMOVED WITHOUT INJURY OR FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771850 HENRY SCHEIN HS 3-0 PGA UNDYED BR 18"/45CM PC31 GAB SURGICAL SPECIALTIES CORPORATION 900-4421 MBCQ750

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention