BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTILENE 4/0 (1,5) 45CM DSMP16 (M) RCP

    MDR report key: 11377436 · Received February 25, 2021

    Report

    Report Number
    3003639970-2021-00046
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Report Date
    February 25, 2021
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAW
    PMA / PMN Number
    K133890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME CODE-BATCH. WE MANUFACTURED (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE (B)(4) UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. ACCORDING TO THE PICTURES RECEIVED, THE LABEL OF THE BOX IS OF OPTILENE 4/0 (1,5) 45CM DSMP16 RCP (REFERENCE G3090630 AND BATCH 120471), BUT THE BOX AND THE PRODUCT INSIDE IS FOR MONOSYN: MONOSYN PRE-PRINTED BOX AND THE PRODUCT INSIDE THE BOX CORRESPONDS TO THE CODE-BATCH 2022036-120473 (MONOSYN VIOLET 2/0 (3) 70CM HR30 (M) RCP). THIS MISTAKE TOOK PLACE IN WAREHOUSE WHEN LABELLING THE PRODUCT BOX. THE OPERATOR TOOK BY MISTAKE A MONOSYN BOX (CODE G2022036 AND BATCH 120473) AND LABELED AS OPTILENE (CODE G3090630 AND BATCH 120471). ACCORDING TO THE CUSTOMER INFORMATION RECEIVED, ONLY ONE BOX HAS BEEN FOUND WITH THIS ISSUE. IN ADDITION, WE HAVE CHECKED THE STOCK IN OUR WAREHOUSE, AND WE HAVE NOT FOUND ANY AFFECTED PRODUCT BOX. ALSO, AS THERE HAVE BEEN NO PREVIOUS COMPLAINTS FOR THIS CODE-BATCH, WE ASSUME THAT THIS IS AN ISOLATED AND ACCIDENTAL BOX. NEVERTHELESS, WE TAKE NOTE OF THE INCIDENCE AND THE PERSONNEL INVOLVED HAS BEEN INFORMED TO AVOID THAT THIS ISSUE HAPPENS AGAIN. 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 FAILURE IN THE PICTURE RECEIVED. WE APOLOGISE FOR ANY INCONVENIENCE THAT THIS ISSUE MAY HAVE CAUSED, AND THANK YOU FOR YOUR COLLABORATION. 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 OPTILENE SUTURE. THE CLIENT REPORTED A LABELLING ERROR: THE BOX IS LABELED AS AN OPTILENE PRODUCT NEVERTHELESS INSIDE IT CONTAINS: MONOSYN HR30, USP20, 70CM (REF 2022036, BATCH 120473). PATIENT WAS NOT AFFECTED. ERROR DETECTED BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275122 OPTILENE 4/0 (1,5) 45CM DSMP16 (M) RCP OTHER SUTURE GAW B. BRAUN SURGICAL, S.A. G3090630 120471

    Patients

    Seq Age Sex Outcome Treatment
    1