BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEEL SUTURE 18"(45CM) 5 B&S

    MDR report key: 7321559 · Received March 7, 2018

    Report

    Report Number
    2210968-2018-71339
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Date of Event
    February 16, 2018
    Report Date
    February 19, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAQ
    UDI-DI
    10705031045439
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. IT WAS REPORTED THAT THE QUANTITY INVOLVED WAS 5, PLEASE CLARIFY IF 5 SUTURES BROKE. DID ALL OF THE SUTURES BREAK DURING ONE OR MULTIPLE PROCEDURES? IF THE SUTURES BROKE DURING MULTIPLE PROCEDURES PLEASE PROVIDE THE FOLLOWING INFORMATION: NUMBER OF PROCEDURES. HAVE ANY OF THE EVENTS BEEN PREVIOUSLY REPORTED TO ETHICON? IF SO, PROVIDE THE RESPECTIVE REFERENCE NUMBER(S). WHAT ARE THE PROCEDURE NAME(S) AND DATE(S)? WERE THERE ANY ADVERSE CONSEQUENCES? IF SO, CLARIFY ANY MEDICAL OR SURGICAL INTERVENTION. WHAT WAS BEING DONE WHEN THE SUTURE BROKE (REMOVAL FROM PACKAGE / DURING PASSAGE THROUGH TISSUE / DURING TYING / POST-OP)?

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #PC-(B)(4). REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. IN THE VISUAL INSPECTION NO DEFECTS WERE FOUND. THE PACKAGING AND SUTURE PRESENTED GOOD CONDITIONS. IN THE FUNCTIONAL INSPECTION OF THE SAMPLES, THEY WERE TESTED FOR DIAMETER, LENGTH STTRENGTH AND PULL TEST AND ALL RESULTS FULLY MET THE MATERIAL SPECIFICATION. AS THE UNOPENED SAMPLES RECEIVED FULLY MET THE REQUIREMENTS IN VISUAL AND FUNCTIONAL TESTS, IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A MYOCARDIAL REVASCULARIZATION ON (B)(6) 2018 AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163194 STEEL SUTURE 18"(45CM) 5 B&S SUTURE, NONABSORBABLE, STEEL GAQ ETHICON INC. AJ5614 10705031045439

    Patients

    Seq Age Sex Outcome Treatment
    1