BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTILENE 4/0 (1,5) 75CM DS19 (M) RCP

    MDR report key: 10332156 · Received July 28, 2020

    Report

    Report Number
    3003639970-2020-00256
    Event Type
    Malfunction
    Date Received
    July 28, 2020
    Date of Event
    February 20, 2020
    Report Date
    November 11, 2020
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAW
    PMA / PMN Number
    K133890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D4 : LOT NUMBER NOT KNOWN, WE HAVE RECEIVED A LIST OF POSSIBLE BATCHES: 119441, 119303, 119463, 119465, 118484 AND 120043. ANALYSIS AND RESULTS: THE INVOLVED BATCH NUMBER IS NOT KNOWN, A LIST OF POSSIBLE BATCHES WAS SUPPLIED. BATCHES SUPPLIED TO END CUSTOMER IN THE TIME RELATED WITH THE COMPLAINT ARE: 119441, 119303, 119463, 119465, 118484 AND 120043. THERE ARE NO PREVIOUS COMPLAINTS OF ANY OF THE POSSIBLE BATCHES. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THE BATCH 119441, (B)(4) UNITS OF BATCH 119303, 2,916 FOR 119463, (B)(4) UNITS OF BATCH 119465, (B)(4) UNITS OF THE BATCH 119484 AND (B)(4) UNITS OF BATCH 120043. THERE ARE NO UNITS OF ANY OF THESE BATCHES IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE NOT RECEIVED ANY SAMPLE FOR ANALISYS. REVIEWED THE BATCH MANUFACTURING RECORDS OF THE POSSIBLE BATCHES, THE PRODUCTS HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLED USP/EP REQUIREMENTS. WITHOUT ANY CLOSED SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. REMARKS: WHEN WORKING WITH OPTILENE® SUTURE MATERIAL, GREAT CARE SHOULD BE TAKEN TO AVOID ANY CRUSHING OR CRIMPING DAMAGE OF THE MONOFILAMENT BY INSTRUMENTS SUCH AS FORCEPS OR NEEDLE HOLDERS. FINAL CONCLUSION: WITHOUT SAMPLES WE ARE NOT IN POSITION OF STUDYING IF THE AFFECTED PRODUCT DOES NOT FULFIL THE SPECIFICATIONS. IN CONSEQUENCE, A PROPER ANALYSIS CANNOT BE DONE AND THE CASE IS NOT CONFIRMED DUE TO LACK OF EVIDENCE. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYSE IT. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED OUR ANALYSIS IS VERY LIMITED. 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 · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH OPTILENE SUTURE. THE CLIENT REPORTED THAT THE THREAD BREAKS DURING SURGERY. FURTHER DATA HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797100 OPTILENE 4/0 (1,5) 75CM DS19 (M) RCP OTHER SUTURE GAW B. BRAUN SURGICAL, S.A. C3090520 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1