BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN QUICK UNDY 3/0(2)70CM DS19(M)DDP

    MDR report key: 11552522 · Received March 23, 2021

    Report

    Report Number
    3003639970-2021-00080
    Event Type
    Malfunction
    Date Received
    March 23, 2021
    Report Date
    April 8, 2021
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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 (BLOCKED) IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED AN OPEN AND UNUSED SAMPLE WITH THE NEEDLE DETACHED FROM THE THREAD. THE SUTURE RECEIVED HAS BEEN VISUALLY CHECKED AND THERE IS A THREAD BROKEN INSIDE THE NEEDLE HOLE AND THE THREAD END IS FRAGILE. THE DETACHMENT OF THE NEEDLE OCCURS BY TOO MUCH THERMAL TREATMENT APPLIED TO THE THREAD ENDS WHICH CAUSES THE THREAD BURNS AND BREAKS EASILY IN THE ATTACHMENT AREA. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE RESULTS OF SAMPLE RECEIVED DOES NOT FULFIL THE SPECIFICATIONS OF THE EUROPEAN PHARMACOPOEIA/B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE SAMPLE RECEIVED. WE APOLOGISE FOR ANY INCONVENIENCE THAT THIS ISSUE MAY HAVE CAUSED, AND THANK YOU FOR YOUR COLLABORATION. ACTIONS ON DISTRIBUTED PRODUCT 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

    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. K170661. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED AN ISSUE WITH NOVOSYN QUICK SUTURE. THE CLIENT REPORTED THAT THE THREAD BREAKS AT THE CRIMPING AREA DURING USE. THERE WERE NO CONSEQUENCES FOR THE PATIENT. INCRIMINATED SAMPLE NOT PRESERVED. NEW SAMPLE PRESERVED. ADDITIONAL DATA OF THE CASE HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454828 NOVOSYN QUICK UNDY 3/0(2)70CM DS19(M)DDP SYNTHETIC ABSORBABLE BRAIDED SUTURE GAM B. BRAUN SURGICAL, S.A. C3046421 120413

    Patients

    Seq Age Sex Outcome Treatment
    1