BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE 2 (5) 150CM HR65 (M) .RCP

    MDR report key: 8221888 · Received January 7, 2019

    Report

    Report Number
    3003639970-2019-00020
    Event Type
    Malfunction
    Date Received
    January 7, 2019
    Date of Event
    December 13, 2018
    Report Date
    March 19, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAW
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER, REGISTRATION NO. 3003639970). EXEMPTION NUMBER: E2014012 G5: K980703 G5: REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. H6 PATIENT CODE: 3191 (NO CODE AVAILABLE) - UMBILICAL PROBLEM, UNKNOWN DIAGNOSIS MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER, REGISTRATION NO. 3003639970). EXEMPTION NUMBER: E2014012 MANUFACTURING SITE EVALUATION: ANALYSIS AND RESULTS: THERE IS A PREVIOUS COMPLAINT OF THIS CODE BATCH REGARDING THREAD BREAKAGE DURING SURGERY. IT WAS CLOSED AS NOT CONFIRMED AFTER THE ANALYSIS. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED 11 CLOSED AND 2 OPEN UNITS. ONE OF THE OPEN SAMPLES RECEIVED IS UNUSED AND THE OTHER IS USED WITH THE THREADS BROKEN, KNOTS ARE NOT UNDONE. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE CLOSED SAMPLES RECEIVED (AND UNUSED OPEN SAMPLE) AND THE RESULTS FULFILL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP). REVIEW OF THE BATCH MANUFACTURING RECORDS SHOWED THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. REMARKS: AS INDICATED IN THE INSTRUCTIONS FOR USE OF THE PRODUCT: "WHEN WORKING WITH PREMILENE SUTURE MATERIALS GREAT CARE SHOULD BE TAKEN TO ENSURE THAT THE USE OF SURGICAL INSTRUMENTS, SUCH AS FORCEPS AND NEEDLE HOLDERS, DO NOT CAUSE ANY CRUSHING OR CRIMPING DAMAGE TO THE SUTURE MATERIAL". FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FULFIL THE SPECIFICATIONS OF EP/ B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. THE CASE IS CONSIDERED NOT CONFIRMED BY EVIDENCE OF THE SAMPLES RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SUTURE BROKE POSTOPERATIVELY. ABOUT 2 HOURS AFTER A VETERINARY SURGERY, IT WAS NOTED THAT THE PREMILENE SUTURE HAD SNAPPED AND AN AREA OF TISSUE HAD OPENED. THE PROCEDURE HAD BEEN PERFORMED ON A CALF WITH AN UNSPECIFIED UMBILICAL ISSUE. THIS MALFUNCTION REQUIRED A RE-OPERATION TO REPAIR THE INCISION. THE CALF'S CONDITION WAS THEN "OK". THE VETERINARIAN WAS CONCERNED ABOUT AN INCREASED RISK OF INFECTION DUE TO A SECOND PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13919 PREMILENE 2 (5) 150CM HR65 (M) .RCP PREMILENE NON-CARDIOVASCULAR GAW B.BRAUN SURGICAL SA B2095585 114252

    Patients

    Seq Age Sex Outcome Treatment
    1