BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATGUT CHROM 2/0 (3.5) 75CM HR37S

    MDR report key: 5724752 · Received June 14, 2016

    Report

    Report Number
    2916714-2016-00456
    Event Type
    Malfunction
    Date Received
    June 14, 2016
    Date of Event
    May 3, 2016
    Report Date
    November 11, 2016
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HO
    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 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. CHIEF OPERATING ROOM, GYNECOLOGISTS AND ANESTHESIOLOGISTS AT THE HOSPITAL, REPORT THAT THE SUTURE BUSTING, WHEN USED IN HOSPITAL PROCEDURES. THREAD BROKE DURING SURGERY.

    Additional Manufacturer Narrative · 1

    RECEIVED SAMPLES: 24 UNITS CATGUT CHROM 2/0 (3.5) 75CM HR37S ARE RECEIVED IN SEALED ORIGINAL PACKAGING. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. (B)(6) UNITS WERE MANUFACTURED AND DISTRIBUTED OF THIS CODE BATCH, THERE ARE NO UNITS IN STOCK. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLS THE OEM REQUIREMENTS. THERE WERE NO DEVIATIONS OR ALTERATIONS WERE IDENTIFIED DURING THIS PROCESS. TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLE RECEIVED AND THE RESULTS FULFILLS THE OEM REQUIREMENTS. FINAL CONCLUSION: COMPLAINT IS NOT JUSTIFIED. RESULTS OF THE SAMPLES RECEIVED FULFILLS THE OEM REQUIREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378493 CATGUT CHROM 2/0 (3.5) 75CM HR37S SUTURES GAL B.BRAUN SURGICAL SA B0560960 514251

    Patients

    Seq Age Sex Outcome Treatment
    1 Other