BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE 2/0 (3) 75CM GS60 (M) POW

    MDR report key: 9933154 · Received April 7, 2020

    Report

    Report Number
    3003639970-2020-00189
    Event Type
    Malfunction
    Date Received
    April 7, 2020
    Date of Event
    January 13, 2020
    Report Date
    July 14, 2020
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAW
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLES RECEIVED: NO SAMPLES HAVE BEEN RECEIVED FOR INVESTIGATION. ANALYSIS AND RESULTS: THE INVOLVED LOT NUMBER IS NOT KNOWN. POSSIBLE BATCHES: 518512, 519044 AND 518513. THERE ARE NO PREVIOUS COMPLAINTS OF THE POSSIBLE CODE-BATCHES. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) OF THE BATCH 518512, (B)(4) OF THE BATCH 519044 AND (B)(4) OF THE BATCH 518513. THERE ARE NO UNITS IN STOCK. THE MANUFACTURING RECORDS HAVE BEEN REVIEWED, AND IT WAS EVIDENT THAT DURING MANUFACTURE OF THE BATCHES, THE PROCESS WAS CONDUCTED IN A NORMAL MANNER. DURING THE FINISHED PRODUCT CONTROLS, ALL PARAMETERS WERE WITHIN SPECIFICATIONS, SO THE BATCH WAS RELEASED WITHOUT INCIDENT. THE RESULTS OF THE ANALYSIS MADE TO THE FINISHED PRODUCT AFTER RELEASE ARE EVALUATED, WHICH INCLUDE: CHARACTERISTICS OF THE THREAD, NEEDLE, LENGTH, DIAMETER. ALL PARAMETERS ARE WITHIN SPECIFICATION. THE RESULTS OF THE ASSEMBLY RESISTANCE TEST ARE VERIFIED, WITH WHICH THE RELEASE FORCE OF THE THREAD AND NEEDLE IS MEASURES. THESE PARAMETERS ARE ALSO WITHIN SPECIFICATIONS. WITH THE INFORMATION AVAILABLE, AND WITH NO SAMPLES AVAILABLE FOR ANALYSIS, WE CANNOT IDENTIFY THE ROOT CAUSE OF THE PROBLEM, AND THEREFORE CANNOT CONFIRM A PRODUCT QUALITY DEFECT. THEREFORE, THE COMPLAINT HAS BEEN CLASSIFIED AS NOT CONFIRMED. HOWEVER, IT HAS BEEN ENTERED INTO OUT DATABASES FOR STATISTICAL PURPOSES. IF SAMPLES ARE AVAILABLE IN THE FUTURE WE WILL RE-OPEN THE CASE. NO CORRECTIVE ACTIONS ARE REQUIRED ON THE MANUFACTURING FLOOR AS THIS IS AN ISOLATED CASE.

    Additional Manufacturer Narrative · 1

    IT IS NOT CLEAR THE BATCH NUMBER RELATED WITH THE REPORT. ACCORDING TO SALES, THERE ARE THREE POSSIBLE BATCHES: 518512, 519044, OR 518513. K980703. 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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PREMILENE SUTURE. A (B)(6)-YEAR-OLD PATIENT, 37.2 WEEKS PREGNANT, WITH PREMATURE RUPTURE OF MEMBRANES, WAS ADMITTED BY TRANSPERITONEAL SEGMENTAL C-SECTION AT 9 PM ON (B)(6) 2020, WITH A SATISFACTORY PROCEDURE AND SUBSEQUENT CLOSURE OF 3 CONTINUOUS CROSSED PLANES, USING NOVOSYN 1 FOR FASCIAL CLOSURE AND PREMILENE 2 FOR INTRADERMAL SUTURE. THE PROCEDURE WAS NOT COMPLICATED, AND ENDS SUCCESSFULLY BUT AFTER 30 MINUTES SHE SHOWED INTENSE ABDOMINAL PAIN "LIKE A TIGHTENING BELT". ON (B)(6) 2020, THE PATIENT SHOWS SIGNS OF FLUID LEAKAGE DUE TO A SURGICAL WOUND, WITH PARTIAL DEHISCENCE, AND FEW TIME LATER WITH COMPLETE DEHISCENCE AND EXPOSURE OF INTESTINAL LOOPS. IMMEDIATE TRANSFER IS GENERATED TO CLOSE THE POSTOPERATIVE DISRUPTION OF THE ABDOMINAL WALL IN WHICH A RUPTURE OF THE MIDDLE THIRD OF THE PREMILENE IS DETECTED WITH SUTURE KNOTS ON BOTH INTEGRAL SIDES, PROCEEDING TO CLOSE THE FASCIA WITH NOVOSYN 1 AND FOR INTRADERMAL SUTURE WITH PREMILENE 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396458 PREMILENE 2/0 (3) 75CM GS60 (M) POW OTHER SUTURE GAW B. BRAUN SURGICAL, S.A. C0095296 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other| R