BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILKAM BLACK 3/0 (2) 75CM HR26

    MDR report key: 9733755 · Received February 20, 2020

    Report

    Report Number
    3003639970-2020-00118
    Event Type
    Malfunction
    Date Received
    February 20, 2020
    Date of Event
    December 2, 2019
    Report Date
    February 20, 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: 36 UNOPENED POUCHES. ANALYSIS AND RESULTS: THERE IS ONE PREVIOUS COMPLAINT OF THE SAME CODE-BATCH REGARDING THE SAME ISSUE. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 12,960 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED 36 CLOSED SAMPLES FOR ANALYSIS. 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 IS AN ISSUE WITH NEEDLE DETACHMENT. THE REPORTER INDICATED THAT REPEATEDLY DURING GENERAL SURGERY (INTRADERMAL PLANE) THE NEEDLE SEPARATES FROM THE THREAD WITH MINIMAL TENSION. THE EVENT OCCURRED PRE-OPERATIVE AND INTRA-OPERATIVELY. PATIENT INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195174 SILKAM BLACK 3/0 (2) 75CM HR26 OTHER SUTURE GAP B.BRAUN SURGICAL SA C0760412 619253

    Patients

    Seq Age Sex Outcome Treatment
    1