BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POL GN BR 4-0 ME-2 2N 18"

    MDR report key: 11655706 · Received April 13, 2021

    Report

    Report Number
    3004365956-2021-00159
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    March 26, 2021
    Report Date
    April 1, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAT
    UDI-DI
    14026704716293
    PMA / PMN Number
    K153076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN(B)(4). ONLY A PORTION OF THE SUTURE WAS RECEIVED WITH ONLY 1 NEEDLE ATTACHED AT ONE END AND CUT AT 8 INCHES. ADDITIONALLY, THE NEEDLE SHOWS SIGNS OF MANIPULATION, MARKS AND CONTAMINATION WAS DETECTED THROUGHOUT THE NEEDLE. THE SUTURE WAS DIMENSIONALLY INSPECTED, SUTURE SPECIFICATION IS 18" LONG HOWEVER DURING THE DIMENSIONAL INSPECTION, THE SUTURE WAS FOUND TO BE 8" .5LONG. NO OTHER TESTING WAS PERFORMED TO THE SUTURE DUE THE CONDITIONS IN WHICH THE SAMPLES ARRIVED. INCOMING INSPECTION RECORDS OF THE NEEDLE LOT INVOLVED IN THE MANUFACTURING OF PRODUCT CODE 6-692 / BATCH 74D1903046 WERE REVIEWED, NO ISSUES OR DISCREPANCIES WERE FOUND. PER IFU L06824 REV. 01 FOR POLYESTER SURGICAL SUTURE - STATEMENT FOR PRECAUTIONS - IN HANDLING THIS OR ANY OTHER SUTURE MATERIAL, CARE SHOULD BE TAKEN TO AVOID DAMAGE FROM HANDLING. AVOID CRUSHING OR CRIMPING DAMAGE DUE TO APPLICATION OF SURGICAL INSTRUMENTS SUCH AS FORCEPS OF NEEDLE HOLDER. ADEQUATE KNOT SECURITY REQUIRES THE ACCEPTED SURGICAL TECHNIQUE OF FLAT, SQUARE TIES WITH ADDITIONAL THROWS AS WARRANTED BY SURGICAL CIRCUMSTANCE AND THE EXPERIENCE OF THE SURGEON. BASED IN THE FINDINGS DURING VISUAL AND DIMENSIONAL INSPECTION, CUSTOMER COMPLAINT CANNOT BE CONFIRMED SINCE THE DEFECT FOUND IS NOT RELATED TO A MANUFACTURING ISSUE BUT MOST LIKELY A CONSEQUENCE OF INTERACTION WITH A NON-TELEFLEX DEVICE. NO ISSUES OR DISCREPANCIES WERE FOUND IN THE DEVICE HISTORY RECORD OF PRODUCT CODE 6-692 / BATCH 74D1903046 THAT CAN BE RELATED TO THE FAILURE MODE REPORTED. BASED IN THE FINDINGS DURING VISUAL AND DIMENSIONAL INSPECTION, CUSTOMER COMPLAINT CANNOT BE CONFIRMED SINCE THE DEFECT FOUND IS NOT RELATED TO A MANUFACTURING ISSUE BUT MOST LIKELY A CONSEQUENCE OF INTERACTION WITH A NON-TELEFLEX DEVICE. MANUFACTURING PERSONNEL WILL BE NOTIFIED OF THIS EVENT FOR AWARENESS.

    Description of Event or Problem · 0

    THE NEEDLE BROKE IN HALF DURING SUTURING OF THE TISSUE. THE PATIENT'S CONDITION WAS REPORTED AS FINE, NO COMPLICATIONS. THE BROKEN NEEDLE BECAME LODGED IN THE PERIOSTEUM AND SOFT TISSUE OF THE LATERAL ORBITAL RIM. IT WAS RETRIEVED AFTER PERFORMING ADDITIONAL DISSECTION.

    Additional Manufacturer Narrative · 1

    QN# (B)(4). NO ISSUES OR DISCREPANCIES WERE FOUND IN THE DEVICE HISTORY RECORD OF PRODUCT CODE 6-692/BATCH 74D1903046 THAT CAN BE RELATED TO THE FAILURE MODE REPORTED. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    THE NEEDLE BROKE IN HALF DURING SUTURING OF THE TISSUE. THE PATIENT'S CONDITION WAS REPORTED AS FINE, NO COMPLICATIONS. THE BROKEN NEEDLE BECAME LODGED IN THE PERIOSTEUM AND SOFT TISSUE OF THE LATERAL ORBITAL RIM. IT WAS RETRIEVED AFTER PERFORMING ADDITIONAL DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552567 POL GN BR 4-0 ME-2 2N 18" SUTURE, NONABSORBABLE, SYNTHET GAT TELEFLEX MEDICAL IPN914473 74D1903046 14026704716293

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention