BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN UNDYED 4/0(1,5)45CM DSMP24(M)RCP

    MDR report key: 11804811 · Received May 11, 2021

    Report

    Report Number
    3003639970-2021-00175
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Report Date
    May 11, 2021
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PREMARKET IDENTIFICATION: 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.: K011375. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE (B)(4) UNITS IN OUR STOCK. WE HAVE RECEIVED ONE CLOSED BOX WITHOUT THE BOX LABEL. THIS ISSUE TOOK PLACE IN THE WAREHOUSE AT THE MOMENT OF PREPARING THE SHIPMENT. THE BOX WAS NOT LABELLED OR WAS UNLABELED BY ERROR, THE OPERATOR DID NOT NOTICE THAT, AND IT WAS DISTRIBUTED TO THE CUSTOMER. WE CONSIDER THIS TO BE AN ISOLATED AND ACCIDENTAL CASE. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE BOX RECEIVED DOES NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, 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. 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 · 1

    IT WAS REPORTED AN ISSUE WITH MONOSYN SUTURE PACKAGING. THE CLIENT REPORTED THAT THE LABEL IS MISSING IN ONE BOX. PATIENT WAS NOT AFFECTED. ERROR DETECTED BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701880 MONOSYN UNDYED 4/0(1,5)45CM DSMP24(M)RCP SYNTHETIC ABSORBABLE MONOFILAR SUTURE GAM B. BRAUN SURGICAL, S.A. C2023634 121117

    Patients

    Seq Age Sex Outcome Treatment
    1