BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEV WH BR 5 KAC-25 1N 24" 1/BX NICELOOP

    MDR report key: 7320957 · Received March 7, 2018

    Report

    Report Number
    3004365956-2018-00053
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Date of Event
    December 20, 2017
    Report Date
    February 12, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAT
    PMA / PMN Number
    K021019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION TOOK PLACE ON ONE (1) SAMPLE RECEIVED FROM PRODUCT CODE SMSL50201 (TEV WH BR 5 KAC-25 1N 24" 1/BX NICELOOP), SAMPLE WAS RECEIVED WITHOUT ITS CORRESPONDING WRAPPING (FOIL) AND SEALED POUCH. NEEDLE HAS ITS CHANNEL SECTION ALREADY CLOSED AND BOTH ENDS OF THE SUTURE SHOWS A MARK INDICATING THAT UNIT WAS PROCESSED AT THE PRESS STATION FOR ITS ATTACHMENT. SUTURE LENGTH DIMENSION WAS TAKEN OBTAINING ACCEPTABLE RESULTS. HOWEVER, ADDITIONAL MEASUREMENTS WILL BE TAKEN AND DOCUMENTED AS PART OF THE INVESTIGATION. NEEDLE CLAMP (ATTACHING) TESTING WAS NOT PERFORMED AS THE SAMPLE WAS RECEIVED ALREADY DETACHED. A COMPLAINT HISTORY REVIEW WAS CONDUCTED ON THE CATALOG NUMBER IN QUESTION FROM 20-DEC-2016 TO 06-MAR-2018. NO COMPLAINTS WERE RECEIVED IN THIS RANGE WITH THE SAME ISSUE. THE DEVICE HISTORY RECORD OF BATCH NUMBER PROVIDED HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. OTHER REMARKS: NO REJECTION REPORT WAS ORIGINATED FOR THE LOT IN QUESTION THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. THE DEVICE HISTORY REVIEW SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. BASED ON THE CONDITION OF THE SAMPLE RECEIVED ADDITIONAL INVESTIGATION ACTIVITIES HAVE BEEN INSTITUTED IN ORDER TO OBTAIN A ROOT CAUSE AND THE APPROPRIATE CORRECTIVE ACTIONS. THE CUSTOMER COMPLAINT IS CONFIRMED BASED ON THE SAMPLE CONDITION (NEEDLE DETACHED). TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE BROKE OFF SUTURE. IT HAPPENED WHEN HE WENT TO PUT THE NEEDLE THROUGH THE PATIENT'S BONE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162867 TEV WH BR 5 KAC-25 1N 24" 1/BX NICELOOP SUTURE, NONABSORBABLE, SYNTHE GAT TELEFLEX MEDICAL 74M1600431

    Patients

    Seq Age Sex Outcome Treatment
    1