BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN UNDYED 5/0 (1)45CM DSMP13(M).RCP

    MDR report key: 11819031 · Received May 13, 2021

    Report

    Report Number
    3003639970-2021-00205
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 23, 2021
    Report Date
    May 13, 2021
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    K011375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 A PICTURE FROM THE CUSTOMER WHICH SHOWS A SUPRAMID PRE-PRINTED BOX AND THE BOX LABEL IS OF A MONOSYN (CODE (B)(4); MONOSYN UNDYED 5/0 (1)45CM DSMP13(M).RCP AND BATCH 120425). ACCORDING TO THE CUSTOMER INFORMATION RECEIVED, ONLY ONE BOX HAS RECEIVED WITH THIS ISSUE AND THE PRODUCT INSIDE THE BOX CORRESPONDS TO THE SAME REFERENCE-BATCH AS BOX LABEL (MONOSYN CODE (B)(4) AND BATCH 120425). THEREFORE, THE BOX LABEL AND THE PRODUCT MATCH PERFECTLY (MONOSYN), BUT THE PRE-PRINTED BOX IS WRONG (SUPRAMID). THIS MISTAKE TOOK PLACE AT THE MOMENT OF SELECTION OF PRE-PRINTED BOX OF THE PRODUCT IN THE WAREHOUSE. THE PERSON WHO WAS CONDITIONING THE PRODUCT, SELECTED A WRONG PRE-PRINTED BOX AND DID NOT NOTICE THAT. AS NO PERVIOUS COMPLAINTS HAVE BEEN RECEIVED FOR THIS CODE-BATCH REGARDING THIS ISSUE, WE CONSIDER THAT THIS IS AN ISOLATED AND ACCIDENTAL BOX. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE PICTURE RECEIVED SHOWS A PRODUCT BOX THAT DOES NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE PICTURE 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 THE PACKAGING OF MONOSYN SUTURE. THE CLIENT REPORTED THAT THE PRODUCT BOX DOES NOT MATCH WITH THE PRODUCT INSIDE THE BOX. THE PRE-PRINTED BOX IS FOR SUPRAMID PRODUCT INSTEAD OF MONOSYN. THE DESCRIPTION ON THE BOX LABEL IS THE SAME AS THE PRODUCT INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713420 MONOSYN UNDYED 5/0 (1)45CM DSMP13(M).RCP SYNTHETIC ABSORBABLE MONOFILAR SUTURE GAM B. BRAUN SURGICAL, S.A. G2023603 120425

    Patients

    Seq Age Sex Outcome Treatment
    1