BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAFILON BLUE 1 (4) 75CM DS39

    MDR report key: 5591144 · Received April 20, 2016

    Report

    Report Number
    2916714-2016-00260
    Event Type
    Malfunction
    Date Received
    April 20, 2016
    Date of Event
    March 31, 2016
    Report Date
    April 19, 2016
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. 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. MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: NO SAMPLES, PICTURES ATTACHED. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME REFERENCE-BATCH. (B)(4) UNITS WERE MANUFACTURED AND DISTRIBUTED OF THIS CODE BATCH. THERE ARE (B)(4) UNITS IN STOCK THAT HAVE BEEN BLOCKED. RECEIVED PICTURES OF A BOX LABELED AS B0935476 (DAFILON BLUE 1(4) 75CM DS39) AND BATCH (B)(4), BUT INSIDE THE (B)(4) UNITS ARE FROM THE REFERENCE 0935476 WITH BATCH (B)(4), WHICH CORRESPONDS TO A DAFILON 2/0. THIS MISTAKE WAS PRODUCED DURING THE PACKAGING STEP AT THE MOMENT OF PREPARING THE SHIPMENT IN THE WAREHOUSE. BOTH PRODUCTS WERE LABELED ONE AFTER THE OTHER. LINE CLEARANCE WAS NOT CORRECTLY DONE. TAKING INTO ACCOUNT THAT NO OTHER CUSTOMER COMPLAINTS HAVE BEEN RECEIVED CONCERNING THIS ISSUE FOR THIS CODE-BATCH, THIS IS CONSIDERED AN ACCIDENTAL AND ISOLATED PROBLEM AND WHOLE BATCH IS CORRECT. NOTE OF THIS INCIDENCE HAS BEEN TAKEN AND THE INVOLVED PERSONNEL HAS BEEN WARNED ABOUT THIS ISSUE. FINAL CONCLUSION: COMPLAINT IS JUSTIFIED. TAKING INTO ACCOUNT THAT THE BOX RECEIVED DOES NOT FULFILL THE OEM REQUIREMENTS. ACTIONS ON PRODUCT: CREDIT NOTE FOR ONE BOX. CORRECTIVE/PREVENTIVE ACTIONS: THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). PRODUCTS OF DIFFERENT ARTICLE ARE PACKED IN THE BOX. MIX-UP: WRONG PRODUCT INSIDE THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248183 DAFILON BLUE 1 (4) 75CM DS39 SUTURES GAR B.BRAUN SURGICAL SA B0932574 613264

    Patients

    Seq Age Sex Outcome Treatment
    1 Other