BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11003516 · Received December 14, 2020

    Report

    Report Number
    3004365956-2020-00263
    Event Type
    Malfunction
    Date Received
    December 14, 2020
    Date of Event
    November 16, 2020
    Report Date
    November 25, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAW
    PMA / PMN Number
    K930738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DHR REVIEW WAS PERFORMED IN PREVIOUS COMPLAINT REPORT WITH NO FINDINGS TO REPORT. ONE EACH SAMPLE OF PRODUCT CODE 833-124 WAS RECEIVED IN A ZIPLOC BAG WITH A DISINFECTION TAG WITHOUT CARRIER. PRODUCT CODE CONFIGURATION IS BULLET TC-43 - CURVED NEEDLE HR26: BULLET TC-43 IS NOT PRESENT HOWEVER THERE ARE SIGNS OF CRIMP IN THE SUTURE WHICH INDICATES THAT A BULLET WAS ATTACHED IN THE SUTURE. THERE ARE NO ISSUES TO REPORT IN THE CURVED NEEDLE HR26 ALSO NO DAMAGES WERE DETECTED THROUGHOUT THE SUTURE. BASED ON THE FINDINGS DURING VISUAL INSPECTION, THERE ARE SIGNS OF CRIMP IN THE SUTURE WHICH INDICATES THAT A BULLET TC-43 WAS ATTACHED TO THE SUTURE. BASED ON THIS FINDING THE 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 ARE GOING TO BE NOTIFIED OF THIS EVENT FOR AWARENESS.

    Description of Event or Problem · 0

    ON 11/16/2020 DURING A PROCEDURE IN THE GYNECOLOGY UNIT, THE SUTURE UNRAVELED AND A METAL FRAGMENT ENDED UP IN THE DISSECTION. IT COULD NOT BE LOCATED. THE PHYSICIAN SPECIFIES THAT THE DEVICE WAS USED WITH CAUTION. IT HAD NO OTHER CONSEQUENCE FOR THE PATIENT. THIS WAS AN ISOLATED INCIDENT. NO PATIENT HARM REPORTED.

    Additional Manufacturer Narrative · 1

    QN#: (B)(4). A VISUAL OR FUNCTIONAL INSPECTION CANNOT BE CONDUCTED SINCE THE SAMPLE INVOLVED IN THE COMPLAINT NOR PICTURES WERE SENT FOR ANALYSIS. NO ADDITIONAL TESTS WERE PERFORMED AS PART OF THIS INVESTIGATION SINCE PRODUCT CODE 833-124 IS NOT IN PRODUCTION. NO ISSUES OR DISCREPANCIES WERE FOUND IN THE DEVICE HISTORY RECORD OF PRODUCT CODE 833-124 / BATCH 74J1902978 THAT CAN BE RELATED TO THE FAILURE MODE REPORTED. A CORRECTIVE ACTION CANNOT BE IMPLEMENTED AT THE TIME SINCE THE SAMPLE INVOLVED IN THE CUSTOMER COMPLAINT WAS NOT SENT FOR ANALYSIS. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED SINCE THE PRODUCT INVOLVED IN THE COMPLAINT NOTIFICATION WAS NOT PROVIDED TO PERFORM A PROPER INVESTIGATION. A VISUAL OR FUNCTIONAL INSPECTION CANNOT BE CONDUCTED SINCE THE SAMPLE INVOLVED IN THE COMPLAINT NOR PICTURES WERE SENT FOR ANALYSIS. NO ADDITIONAL TESTS WERE PERFORMED AS PART OF THIS INVESTIGATION SINCE PRODUCT CODE 833-124 IS NOT IN PRODUCTION. NO ISSUES OR DISCREPANCIES WERE FOUND IN THE DEVICE HISTORY RECORD OF PRODUCT CODE 833-124 / BATCH 74J1902978 THAT CAN BE RELATED TO THE FAILURE MODE REPORTED. A CORRECTIVE ACTION CANNOT BE IMPLEMENTED AT THE TIME SINCE THE SAMPLE INVOLVED IN THE CUSTOMER COMPLAINT WAS NOT SENT FOR ANALYSIS. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED SINCE THE PRODUCT INVOLVED IN THE COMPLAINT NOTIFICATION WAS NOT PROVIDED TO PERFORM A PROPER INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2020 DURING A PROCEDURE IN THE GYNECOLOGY UNIT, THE SUTURE UNRAVELED AND A METAL FRAGMENT ENDED UP IN THE DISSECTION. IT COULD NOT BE LOCATED. THE PHYSICIAN SPECIFIES THAT THE DEVICE WAS USED WITH CAUTION. IT HAD NO OTHER CONSEQUENCE FOR THE PATIENT. THIS WAS AN ISOLATED INCIDENT. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1467726 DEK BL MF 0 TC-43/HR 26 2N SUTURE, NONABSORBABLE, SYNTHE GAW TELEFLEX MEDICAL IPN000861 74J1902978

    Patients

    Seq Age Sex Outcome Treatment
    1