BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILKAM BLACK 3/0 (2) 75CM HR26

    MDR report key: 9711517 · Received February 14, 2020

    Report

    Report Number
    3003639970-2020-00082
    Event Type
    Malfunction
    Date Received
    February 14, 2020
    Date of Event
    January 15, 2020
    Report Date
    February 14, 2020
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510K: 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. K990089. INVESTIGATION: SAMPLES RECEIVED: 27 UNOPENED POUCHES AND 2 OPENED. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED 29 CLOSED SAMPLES AND 2 OPENED (ONE OF THEM WITH THE NEEDLE DETACHED FROM THE THREAD). WE HAVE TESTED THE NEEDLE ATTACHMENT STRENGTH OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS DO NOT FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP). REVIEWED THE BATCH MANUFACTURING RECORD, THIS BATCH HAS AN INCIDENCE BUT WAS RELEASED INTO THE MARKET FULFILLING USP/EP AND B.BRAUN SURGICAL REQUIREMENTS. NEEDLE ATTACHMENT STRENGTH RESULTS BEFORE RELEASING THE PRODUCT WERE 0.73 KGF IN AVERAGE AND 0.59 KGF IN MINIMUM (EP REQUIREMENTS: 0.69 KGF IN AVERAGE AND 0.35 KGF IN MINIMUM). FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE RESULTS OF SAMPLES RECEIVED DO NOT FULFIL THE SPECIFICATIONS OF THE EUROPEAN PHARMACOPOEIA/B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED. ACTIONS ON PRODUCT DISTRIBUTED OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. NO CORRECTIVE/PREVENTIVE ACTIONS NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NEEDLE DETACHMENT. THE REPORTER INDICATED THAT DURING A SURGICAL PROCEDURE OF A STOMACH INTERVENTION THE SUTURE IS DETACHED FROM THE NEEDLE. PATIENT INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174635 SILKAM BLACK 3/0 (2) 75CM HR26 OTHER SUTURE GAP B.BRAUN SURGICAL SA C0760412 619253

    Patients

    Seq Age Sex Outcome Treatment
    1