BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOSYN VIOLET 6/0(0.7)20CM 2XVLM8 (M

    MDR report key: 12882661 · Received November 29, 2021

    Report

    Report Number
    3003639970-2021-00618
    Event Type
    Injury
    Date Received
    November 29, 2021
    Report Date
    January 4, 2022
    Manufacturer
    B. BRAUN SURGICAL, S.A.U.
    Product Code
    GAM
    PMA / PMN Number
    K122734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: THE BATCH IS NOT KNOWN. THE POSSIBLE BATCHES (LOT NUMBERS) REPORTED ARE THE FOLLOWING: 120452, 120454, 120481, 120096, 120075. THERE IS ONE PREVIOUS CASE THAT INVOLVES THE POSSIBLE BATCHES: 120452, 120481 AND 120096. IT WAS REGARDING THE SAME ISSUE AND CLOSED AS NOT CONFIRMED AFTER THE ANALYSIS. THERE ARE NO PREVIOUS COMPLAINTS OF THE OTHER TWO POSSIBLE BATCHES: 120454, 120075. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THE BATCHES 120452, 120454 AND 120481, (B)(4) UNITS OF BATCH 120096 AND (B)(4) UNITS OF BATCH 120075. THERE ARE NO UNITS IN STOCK OF THE POSSIBLE CODE-BATCHES REPORTED. WE HAVE NOT RECEIVED ANY SAMPLE TO ANALYZE THIS CASE. WITHOUT ANY SAMPLE, WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. REVIEWED THE BATCH MANUFACTURING RECORDS, THESE PRODUCTS HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. AS MENTIONED IN THE INSTRUCTIONS FOR USE (IFU) OF THE PRODUCT, SUTURE MATERIALS ARE USED PRIMARILY FOR ADAPTATION OF THE WOUND EDGES TO RENDER POSSIBLE AN UNDISTURBED WOUND HEALING. DURING THE USE OF NOVOSYN® SUTURES A MILD INFLAMMATORY REACTION MAY OCCUR, WHICH IS TYPICAL FOR AN ENDOGENOUS REACTION TO A FOREIGN BODY. AS TIME PASSES THE SUTURE MATERIAL IS ENCAPSULATED BY FIBROUS CONNECTIVE TISSUE. FINAL CONCLUSION: WITHOUT SAMPLES WE ARE NOT IN POSITION OF STUDYING IF THE POSSIBLE AFFECTED PRODUCTS DO NOT FULFIL THE SPECIFICATIONS. IN CONSEQUENCE, A PROPER ANALYSIS CANNOT BE DONE, AND THE CASE IS NOT CONFIRMED DUE TO LACK OF EVIDENCE. ANYWAY, WE TAKE NOTE OF THIS INCIDENCE AND IF SAMPLES OR MORE INFORMATION ARE RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYSE IT. NEVERTHELESS, ACCORDING TO THE BATCH MANUFACTURING RECORDS REVIEW, THE POSSIBLE PRODUCTS COMPLY WITH B. BRAUN SURGICAL SPECIFICATIONS AND EP REQUIREMENTS. THEREFORE, WE DO NOT SEE ANY MANUFACTURING FAULT OR MATERIAL DEFECT THAT COULD HAVE CAUSED THE INCIDENCE. 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.

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH NOVOSYN SUTURE. THE CUSTOMER REPORTED A VERY STRONG CONJUNCTIVAL REACTION DUE TO THE MUSCLE SUTURE AFTER SKELETAL SURGERY. SUSPECTED SUTURE GRANULOMA. INOCULATION WAS NEGATIVE. SKELETAL SURGERY WAS ON (B)(6) 2021 WHERE LEFT MEDIAL RECTUS MUSCLE RECESSION WAS PERFORMED. THE NOVOSYN USP 6/0 SUTURE WAS USED FOR MUSCLE FIXATION TO THE SCLERA. SUBSEQUENTLY, STANDARD TREATMENT WITH EYE DROPS WAS DONE FROM THE SURGERY UNTIL (B)(6) 2021. ON (B)(6) 2021, THE PATIENT CONTACTED THE WARD DUE TO INCREASED REDNESS IN THE LEFT EYE SINCE DISCONTINUATION OF EYE DROPS. THERE WAS LOCALIZED CONJUNCTIVAL REACTION DUE TO MUSCLE ADHESION, FOCAL REDNESS AND YELLOWING AND SWELLING. THERE WAS NO GROWTH IN THE GRAFT. REPROCESSING WITH EYE DROPS FOR THREE WEEKS, THEN REMISSION OF SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1783172 NOVOSYN VIOLET 6/0(0.7)20CM 2XVLM8 (M SYNTHETIC ABSORBABLE BRAIDED SUTURE GAM B. BRAUN SURGICAL, S.A.U. G0068733

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other