BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEV GN BR 0 TC-43 2N 48"

    MDR report key: 11088599 · Received December 29, 2020

    Report

    Report Number
    3011137372-2020-00301
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    December 8, 2020
    Report Date
    December 10, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAT
    PMA / PMN Number
    K021019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). 1 EACH SAMPLE OF PRODUCT CODE 833-113 WAS RECEIVED ON A ZIPLOC BAG WITH A DISINFECTION TAG WITHOUT CARRIER. PRODUCT CODE CONFIGURATION IS BULLET TC-43 - BULLET TC-43: ONLY A PORTION OF THE SUTURE ARRIVED UNDER THE FOLLOWING CONDITIONS. THE SUTURE WAS RECEIVED WITHOUT TC-43 BULLET (NO ATTACHMENT ON BOTH SIDES) IN ADDITION THE SUTURE SHOW SIGNS OF MANIPULATION, IT IS ALSO DETECTED THAT IN ONE SIDE OF THE SUTURE IT HAS A CUT AND IN THE OTHER SIDE OF THE SUTURE A TEAR. SUTURE SPECIFICATION IS 48" LONG; DURING DIMENSIONAL INSPECTION, THE SUTURE WAS FOUND TO BE 23 " LONG. A FUNCTIONAL INSPECTION CANNOT BE EXECUTED AS THE SAMPLE SUTURE HAS NO BULLETS ATTACHED. 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 THE INTERACTION WITH A NON-TELEFLEX DEVICE. 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 THE INTERACTION WITH A NON-TELEFLEX DEVICE. PER HA-000039 REV. 12 LINE: OPERATIONAL HAZARDS - INCORRECT OR INAPPROPRIATE OUTPUT OR FUNCTIONALITY - NEEDLE DISENGAGES/SEPARATES FROM SUTURE WHEN USED WITH AND ACCESSORY AND/OR SUTURING DEVICE: WHEN THE SUTURE IS USED WITH AN ACCESORY AND/OR SUTURING DEVICE THE SUTURE MAYBE SUBJECT TO FORCES THAT ARE UNDER CONTROL OF THE SURGEON USING THE DEVICE. ADDITIONALLY, THERE ARE QUALITY CONTROLS IN PLACE WHICH ARE INSPECTED IN QUALITY FORM QA-SUT-001/F2 AND IN FORM WI-002567/F1 REV. 01 ALSO DURING THE MANUFACTURING PROCESS ALL THE NEEDLE ATTACHMENTS GET TESTED WITH A LOW PULL TESTER PER MANUFACTURING PROCEDURE 680-86-624 STEP 6.8.2. MANUFACTURING PERSONNEL IS GOING TO BE NOTIFIED IF THIS EVENT FOR AWARENESS.

    Additional Manufacturer Narrative · 0

    (B)(4). A DHR REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. PER HA-000039 REV. 12 LINE: OPERATIONAL HAZARDS - INCORRECT OT INAPPROPRIATE OUTPUT OR FUNCTIONALITY - NEEDLE DISENGAGES/SEPARATES FROM SUTURE WHEN USED WITH AN ACCESORY AND/OR SUTURING DEVICE: WHEN THE SUTURE IS USED WITH AN ACCESORY AND/OR SUTURING DEVICE THE SUTURE MAYBE SUBJECT TO FORCES THAT ARE UNDER CONTROL OF THE SURGEON USING THE DEVICE. A CORRECTIVE ACTION CANNOT BE DETERMINED DUE TO THE LACK OF BATCH NUMBER TO PERFORM A PROPER INVESTIGATION AND DETERMINE A ROOT CAUSE. CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFORMATION PROVIDED, TO PERFORM AN INVESTIGATION AND DETERMINE THE SOURCE OF DEFECT REPORTED IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED ON THIS COMPLAINT. 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 SAMPLE BECOMES AVAILABLE THIS INVESTIGATION WILL BE UPDATED WITH THE EVALUATION RESULTS.

    Description of Event or Problem · 0

    REPORTED ISSUE: FIRING OF THE CAPIO SLIM WAS PERFORMED AND THERE WAS A NOISE WHEN THE NEEDLE HAS RETURNED AND THE SUTURE WAS SEPARATED (WAS ABLE TO RECOVER). PHYSICIAN'S COMMENT: THERE WAS A VARIATION ON THE QUALITY. THE PHYSICIAN WAS THE MOST FREQUENT USER OF CAPIO SLIM IN THE COUNTRY. PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE SCOPE USED: UNKNOWN GUIDEWIRE USED: UNKNOWN GENERATOR/CONTROLLER USED: UNKNOWN OTHER USED: UNKNOWN.

    Description of Event or Problem · 0

    REPORTED ISSUE: FIRING OF THE CAPIO SLIM WAS PERFORMED AND THERE WAS A NOISE WHEN THE NEEDLE HAS RETURNED AND THE SUTURE WAS SEPARATED (WAS ABLE TO RECOVER). PHYSICIAN'S COMMENT: THERE WAS A VARIATION ON THE QUALITY. THE PHYSICIAN WAS THE MOST FREQUENT USER OF CAPIO SLIM IN THE COUNTRY. PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE. SCOPE USED: UNKNOWN GUIDEWIRE USED: UNKNOWN.. GENERATOR/CONTROLLER USED: UNKNOWN OTHER USED: UNKNOWN.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORTED ISSUE: FIRING OF THE CAPIO SLIM WAS PERFORMED AND THERE WAS A NOISE WHEN THE NEEDLE HAS RETURNED AND THE SUTURE WAS SEPARATED (WAS ABLE TO RECOVER). PHYSICIAN'S COMMENT: THERE WAS A VARIATION ON THE QUALITY. THE PHYSICIAN WAS THE MOST FREQUENT USER OF CAPIO SLIM IN THE COUNTRY. PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE SCOPE USED: UNKNOWN. GUIDEWIRE USED: UNKNOWN. GENERATOR/CONTROLLER USED: UNKNOWN OTHER USED: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550778 TEV GN BR 0 TC-43 2N 48" SUTURE, NONABSORBABLE, SYNTHE GAT TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 N/A.| N/A.