BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BON GN BR 0 TC-43 2N 48"

    MDR report key: 6085841 · Received November 8, 2016

    Report

    Report Number
    3004365956-2016-00418
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    October 12, 2016
    Report Date
    October 20, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAM
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION WAS PERFORMED TO SAMPLE RECEIVED OF PRODUCT CODE 833-213LP (BON GN BR 0 TC-43 2N 48") WHERE ONLY ONE SECTION OF SUTURE IS RETURNED, SUTURE CONTAINS IN ONE END THE BULLET, IN THE OTHER END LOOKS CUT. THE DEVICE HISTORY RECORD OF THE FG INVOLVED WITH BATCH NUMBER HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. INCOMING INSPECTION RECORDS OF THE SUTURE P/N 109347 BATCH NUMBER 07J1400113 FROM SUPPLIER TELEFLEX MEDICAL INC. (B)(4) DOESN'T SHOW ANY QUALITY ISSUES REGISTERED DURING INSPECTION. ALTHOUGH THE CONDITION REPORTED IS OBSERVED BASED ON SAMPLE PROVIDED, THERE IS NO SUFFICIENT EVIDENCE TO ASSURE THIS ISSUE WAS ORIGINATED DURING THE MANUFACTURING PROCESS. A VENDOR NOTIFICATION WILL BE SEND IN ORDER TO NOTIFY ABOUT THIS CUSTOMER COMPLAINT. THE DHR REVIEWED SHOWED THAT THERE WERE NO ISSUES RELATED TO THE REPORTED FAILURE MODE NEITHER ON THE PRODUCT NOR ITS COMPONENTS DURING THE MANUFACTURE OF THIS MATERIAL. ALTHOUGH THE CONDITION REPORTED IS OBSERVED BASED ON SAMPLE PROVIDED, THERE IS NO SUFFICIENT EVIDENCE TO ASSURE THIS ISSUE WAS ORIGINATED DURING THE MANUFACTURING PROCESS. THE ROOT CAUSE FOR THE CONDITION REPORTED COULD NOT BE IDENTIFIED. (B)(4) FACILITY WILL CONTINUE TO TRACK AND TREND THIS FAILURE MODE. A VENDOR NOTIFICATION WILL BE SEND IN ORDER TO NOTIFY ABOUT THIS CUSTOMER COMPLAINT. CONCLUSION - NO CONCLUSION CODE AVAILABLE THAT COULD ACCURATELY DESCRIBE THAT THE COMPLAINT WAS CONFIRMED, BUT THE ROOT CAUSE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD OF BATCH NUMBER (B)(4) HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. NO REJECTION REPORT WAS ORIGINATED FOR THE LOT IN QUESTION THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. AN ATTEMPT TO DUPLICATE THE FAILURE MODE WAS MADE BUT AT THE TIME THERE IS NO INVENTORY OF THE INVOLVED PRODUCT CODE AVAILABLE AT THE FACILITY NOR IS BEING MANUFACTURED AT THE TIME. IF THE DEFECTIVE SAMPLES BECOME AVAILABLE AT A LATER DATE, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY. NO CORRECTIVE ACTIONS CAN BE IMPLEMENTED DUE THE LACK OF PRODUCT SAMPLE TO PERFORM A PROPER INVESTIGATION AND DETERMINE THE ROOT CAUSE. THEREFORE, CUSTOMER COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    UPON REMOVING THE DEVICE FROM THE PATIENT THE SCRUB NURSE NOTICED THAT THE NEEDLE WAS MISSING. AN X-RAY WAS PERFORMED AND THE NEEDLE LOCATION WAS CONFIRMED. RETRIEVAL WAS NOT POSSIBLE. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    UPON REMOVING THE DEVICE FROM THE PATIENT THE SCRUB NURSE NOTICED THAT THE NEEDLE WAS MISSING. AN X-RAY WAS PERFORMED AND THE NEEDLE LOCATION WAS CONFIRMED. RETRIEVAL WAS NOT POSSIBLE. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    UPON REMOVING THE DEVICE FROM THE PATIENT THE SCRUB NURSE NOTICED THAT THE NEEDLE WAS MISSING. AN X-RAY WAS PERFORMED AND THE NEEDLE LOCATION WAS CONFIRMED. RETRIEVAL WAS NOT POSSIBLE. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736630 BON GN BR 0 TC-43 2N 48" GAM TELEFLEX MEDICAL 74A1500127

    Patients

    Seq Age Sex Outcome Treatment
    1