BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE 0 (3.5) 75CM DS30 (M)

    MDR report key: 5651720 · Received May 12, 2016

    Report

    Report Number
    2916714-2016-00375
    Event Type
    Malfunction
    Date Received
    May 12, 2016
    Date of Event
    April 22, 2016
    Report Date
    May 12, 2016
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAW
    PMA / PMN Number
    K980703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 1 BOX (36 UNOPENED RACEPACKS). ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. RECEIVED 1 BOX WHICH CONTAINS 36 POUCHES OF THE CODE-BATCH 2090270-115511 (PREMILENE 2/0 (3) 75CM HS26) INSTEAD OF THE CODE-BATCH 2090248-115505. PRODUCTS TRACEABILITY HAS BEEN CHECKED AND IT HAS BEEN DETERMINED THAT THIS MIX-UP TOOK PLACE IN THE MANUFACTURING LINE IN THE PACKAGING AREA. BOTH PRODUCTS WERE PACKED IN THE SAME LINE AND SAME DAY 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, IT IS CONSIDERED THIS IS AN ISOLATED AND ACCIDENTAL UNIT AND CLAIM IS JUSTIFIED, BUT THE WHOLE BATCH IS CORRECT. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE BOX CONTAINS WRONG PRODUCT INSIDE, IT IS CONSIDERED THAT THE COMPLAINT IS JUSTIFIED. WE APOLOGISE FOR ANY INCONVENIENCE THAT THIS ISSUE MAY HAVE CAUSED AND THANK YOU FOR YOUR COLLABORATION. ACTIONS ON DISTRIBUTED PRODUCT OF THIS REFERENCE/BATCH: SEND A CREDIT NOTE FOR ONE BOX OF PRODUCT AS A COMPENSATION. CORRECTIVE/PREVENTIVE ACTIONS: THERE IS AN IMPROVEMENT PROJECT LEAN_01_2012 THAT INCLUDES THE ANALYSIS OF THE ORIGIN OF ALL POSSIBLE MIX-UPS AND IMPLEMENTATION OF ACTIONS. ONE OF THE ACTIONS INCLUDED IN THESE PROJECTS IS AUTOMATIC PACKAGING. THIS WOULD AVOID THAT UNITS OF ANOTHER REFERENCE ARE PACKED.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: GERMANY. WRONG MATERIAL / SUTURE IN THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304998 PREMILENE 0 (3.5) 75CM DS30 (M) SUTURES GAW B.BRAUN SURGICAL SA C2090248 115505V004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other