BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEK BL MF 0 TC-43/HR 26 2N 36"

    MDR report key: 6402325 · Received March 14, 2017

    Report

    Report Number
    3004365956-2017-00100
    Event Type
    Malfunction
    Date Received
    March 14, 2017
    Date of Event
    February 13, 2017
    Report Date
    February 13, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    MFJ
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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. VISUAL INSPECTION WAS PERFORMED TO ONE (1) SAMPLE OF PRODUCT CODE 833-124 (DEK BL MF 0 TC-43/HR 26 2N 36") WHERE ONLY THE SUTURE WAS RECEIVED, THE END OF SUTURE LOOKS TEARED. NO PACKAGING OR ADDITIONAL COMPONENTS (BULLET AND NEEDLE) WERE RETURNED. AN ATTEMPT TO DUPLICATE THE FAILURE MODE WAS NOT MADE DUE AT THE TIME THERE IS NO INVENTORY OF THE INVOLVED PRODUCT CODE AVAILABLE AT THE FACILITY NOR IS BEING MANUFACTURED AT THE TIME. 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. 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 OTHER REMARKS: SPECIFICATIONS. SUTURE P/N 104143 LOT 07B1600103 WITH DYE LOT 07L1500285 WAS USED FOR THE FINAL ASSEMBLY, SUPPLIER AND INCOMING INSPECTION RECORDS SHOW NO QUALITY ISSUES EITHER. NEEDLE P/N H118493 LOT MDNW240 WAS USED FOR THE FINAL ASSEMBLY, SUPPLIER AND INCOMING INSPECTION RECORDS SHOW NO QUALITY ISSUES EITHER. BULLET P/N 143601 LOT 9695-013522-001 WAS USED FOR THE FINAL ASSEMBLY, SUPPLIER AND INCOMING INSPECTION RECORDS SHOW NO QUALITY ISSUES EITHER. ALTHOUGH THE SUTURE RETURNED SHOWS NO BULLET AND NEEDLE ATTACHED, THERE IS NO SUFFICIENT EVIDENCE TO ASSURE THAT THIS FAILURE MODE WAS ORIGINATED DURING THE MANUFACTURING PROCESS. THE ROOT CAUSE FOR THIS CONDITION REPORTED COULD NOT BE IDENTIFIED, HOWEVER PERSONNEL INVOLVED ON THE MANUFACTURING OF THIS PRODUCT HAS BEEN NOTIFIED. THE NUEVO LAREDO FACILITY WILL CONTINUE TRACKING AND TRENDING THIS FAILURE MODE.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ATTEMPT TO DUPLICATE THE FAILURE MODE WAS MADE BUT WITHOUT SATISFACTORY RESULTS IF DEFECTIVE SAMPLES BECOME AVAILABLE AT A LATER DATE, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY. THE DEVICE HISTORY RECORD OF BATCH NUMBER 74H1600336 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; THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO THE MANUFACTURER'S SPECIFICATIONS. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE THE LACK OF PRODUCT SAMPLE TO PERFORM A PROPER INVESTIGATION AND DETERMINE THE ROOT CAUSE. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    THE BULLET TIP CAME OFF IN THE PATIENT AND IT WAS NOT RETRIEVED. THE PATIENT'S CONDITION WAS REPORTED AS UNKNOWN.

    Description of Event or Problem · 1

    THE BULLET TIP CAME OFF IN THE PATIENT AND IT WAS NOT RETRIEVED. THE PATIENT'S CONDITION WAS REPORTED AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185044 DEK BL MF 0 TC-43/HR 26 2N 36" MFJ TELEFLEX MEDICAL 74H1600336

    Patients

    Seq Age Sex Outcome Treatment
    1