BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMICRON GREEN 3/0 (2) 17X45CM

    MDR report key: 14041835 · Received April 7, 2022

    Report

    Report Number
    3003639970-2022-00142
    Event Type
    Malfunction
    Date Received
    April 7, 2022
    Date of Event
    March 18, 2022
    Report Date
    April 7, 2022
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAT
    PMA / PMN Number
    K012201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME 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 AN OPEN BOX LABELED AS PREMICRON GREEN 3/0 (2) 17X45CM; CODE C0120050 AND BATCH 621195 THAT CONTAINS 30 UNOPENED POUCHES, 28 OF THE SAME CODE-BATCH AS THE PRODUCT BOX (0120050-621195) AND 2 OF ANOTHER REFERENCE-BATCH (0120009-617441; PREMICRON GREEN 0 (3,5) 10X45CM DDP). ACCORDING TO THE CUSTOMER INFORMATION RECEIVED, THE MISSING UNITS IN THE BOX WERE ALSO FROM THE WRONG CODE-BATCH 0120009-617441). UPON INVESTIGATION, THE ORIGIN OF THIS MIX-UP COULD NOT BE DETERMINED. CHECKING THE TRACEABILITY, BOTH PRODUCTS DID NOT OVERLAP DURING THE PRODUCTION PROCESS OR IN THE SAME WAREHOUSE. THEREFORE, THIS MIX-UP PROBABLY TOOK PLACE OUTSIDE BRAUN SURGICAL SPAIN FACILITIES. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. WE CONSIDER THAT THIS COMPLAINT IS CONFIRMED DUE TO THE EVIDENCE OF THE SAMPLES RECEIVED. HOWEVER, THE ROOT-CAUSE COULD NOT BE IDENTIFIED. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE BOX RECEIVED CONTAINS SOME UNITS OF ANOTHER CODE-BATCH, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE FAILURE IN THE SAMPLES RECEIVED. 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. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH PREMICRON SUTURE. THE CLIENT REPORTED THAT IN THE ORIGINAL BOX OF ARTICLE C0120050 SOME PACKAGES OF PRODUCT WITH ARTICLE C0120009 WERE FOUND. NO MORE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1913770 PREMICRON GREEN 3/0 (2) 17X45CM PREMICRON NON-CARDIOVASCULAR SUTURE GAT B. BRAUN SURGICAL, S.A. C0120050 621195

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown