BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATGUT CHROM 0 (4) 90CM HR37S

    MDR report key: 6159543 · Received December 9, 2016

    Report

    Report Number
    2916714-2016-01015
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    October 17, 2016
    Report Date
    March 20, 2017
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR ANY OTHER TECHNOLOGICAL CHARACTERISTICS WITH A MEDICAL DEVICE THAT IS REGISTERED WITHIN THE U.S. (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING H3 OTHER TEXT: DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: COLOMBIA. IT WAS REPORTED THAT THE THREAD FRAYED DURING SURGERY.

    Additional Manufacturer Narrative · 1

    RECEIVED SAMPLES: CUSTOMER DIDN'T ATTACH SAMPLES OF THE COMPLAINT BATCH PRELIMINARY ANALYSIS: STOCK REVIEW: ONCE THE STOCK OF THIS BATCH IN WAREHOUSE WAS REVIEWED, IT WAS VERIFIED THAT CURRENTLY THERE ARE NOT UNITS OF THIS BATCH NUMBER. IMPORTED/MANUFACTURED UNITS: IT WAS MADE THE LOT TRACING AND IT WAS VERIFIED THAT THEY WERE MANUFACTURED (B)(4) UNITS OF THIS BATCH NUMBER. DISTRIBUTED QUANTITY: ALL UNITS WERE DISTRIBUTED TO 10 CUSTOMERS, WHICH ARE LOCATED IN NEXT CITIES: (B)(6). BACKGROUND: COMPLAINT DATABASE WAS CHECKED AND IT WAS VERIFIED THAT TO THE DATE, THERE AREN'T REPORTS RELATED TO THIS CAUSE AND BATCH NUMBER. BATCH RECORD: DOCUMENTATION OF THE BATCH WAS REVIEWED, IN PROCESS AND FINISHED PRODUCT QUALITY CONTROLS WERE CHECKED AND THERE WEREN'T FOUND DEVIATIONS, EITHER ALTERATIONS DURING PROCESS RESULTS FOR BATCH RELEASE: THE OBTAINED RESULTS FOR BATCH RELEASING, IN REGARD TO RESISTANCE TO TENSION IN THE KNOT, WITH MINIMUM OF 2.87 KGF, MAXIMUM OF 3.91 KGF AND MEAN OF 3.42 KGF, MET THE REQUIREMENTS FOR THIS TYPE OF SUTURE, IT WAS NOT OBSERVED FRAYING (USP: MEAN LIMIT: 2.77 KGF, MINIMUM 1.45 KGF). SAMPLE ANALYSIS: AS LONG AS IT WAS NOT RECEIVED ANY SAMPLE AND THERE AREN'T AVAILABLE UNITS IN WAREHOUSE, IT IS NOT POSSIBLE TO CARRY OUT AN INVESTIGATION WHICH DETERMINES THE ROOT CAUSE OF THIS INCIDENT. CONCLUSIONS: THE COMPLAINT IS CLASSIFIED AS "NOT EVALUABLE", SINCE THERE AREN'T AVAILABLE SAMPLES FOR INVESTIGATION, IT IS NOT POSSIBLE TO REACH AN ACCURATE CONCLUSION ON THE OCCURRED INCIDENT. PLEASE TAKE INTO ACCOUNT THAT IN ORDER TO CARRY OUT AN APPROPRIATE ASSESSMENT TO COMPLAINTS, IT IS NECESSARY TO ATTACH AT LEAST 5 UNITS OF THE SAME BATCH IN CLOSED PACKAGE, IN ORDER TO PERFORM THE ESTABLISHED USP ESSAYS. ACTIONS:NO CORRECTIVE OR PREVENTIVE ACTIONS ARE TAKEN ON THIS COMPLAINT, SINCE FROM REVIEW THERE WEREN'T IDENTIFIED PRODUCT FAILURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808402 CATGUT CHROM 0 (4) 90CM HR37S SUTURES GAL B.BRAUN SURGICAL SA B0565113 516091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other