BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILKAM BLACK 2/0 (3) 75CM HS30

    MDR report key: 9521553 · Received December 26, 2019

    Report

    Report Number
    3003639970-2019-00921
    Event Type
    Malfunction
    Date Received
    December 26, 2019
    Date of Event
    November 27, 2019
    Report Date
    January 20, 2020
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLES RECEIVED: (B)(4) CLOSED BOX (CONTAINS (B)(4) UNOPENED POUCHES). ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE 144 UNITS IN OUR STOCK. WE HAVE RECEIVED ONE CLOSED BOX THAT IS STAINED OF BLOOD. THIS DEFECT WAS PRODUCED DURING THE PACKAGING PROCESS IN THE MANUFACTURING LINE AND THE PERSONNEL INVOLVED DID NOT REALIZE TO REPLACE THE DIRTY BOX. WE HAVE CONDUCTED A REVIEW OF THE RECORDS PERTAINING TO THAT PERIOD AND NO INJURY OR ABNORMALITY WAS RECORDED. HOWEVER, WE HAVE INFORMED THE PERSONNEL INVOLVED TO ENSURE THAT THIS DOES NOT HAPPEN AGAIN. TAKING INTO ACCOUNT THAT NO OTHER COMPLAINTS HAVE BEEN RECEIVED CONCERNING THIS ISSUE FOR THIS CODE-BATCH, WE CONSIDER THAT THIS IS AN ACCIDENTAL AND ISOLATED BOX. FINAL CONCLUSION: WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE FAILURE IN THE BOX 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. YOU WILL RECEIVE A CREDIT NOTE FOR ONE BOX OF PRODUCT AS COMPENSATION. 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.

    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. WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BOX IS DAMAGED AND THERE IS BLOOD RESIDUE. THE REPORTER INDICATED THAT THE SUTURE BOX IS DAMAGED AND THERE ARE SOME BLOOD RESIDUES INSIDE THE WRAPPED PACKAGING AT THE FOIL/BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313650 SILKAM BLACK 2/0 (3) 75CM HS30 OTHER SUTURE GAP B.BRAUN SURGICAL SA C0764779 619313V153

    Patients

    Seq Age Sex Outcome Treatment
    1