BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 2/0 (3) 70CM HS 23 (M)

    MDR report key: 4992692 · Received August 7, 2015

    Report

    Report Number
    2916714-2015-00675
    Event Type
    Malfunction
    Date Received
    August 7, 2015
    Report Date
    August 4, 2015
    Manufacturer
    B.BRAUN SURGICAL S.A.
    Product Code
    GAM
    PMA / PMN Number
    K122734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 6 UNOPENED POUCHES OF MONOSYN 3/0 (REF 0022015, BATCH 115115), 6 UNOPENED RACE-PACKS OF PREMILENE 4/0 (REF. 2090520, BATCH 115084) AND 12 UNOPENED RACE-PACKS OF PREMILENE 3/0 (REF. 2090235, BATCH 115054). ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS THIS REFERENCE-BATCH. PREMILENE/MONOSYN SET SHOULD CONTAIN 6 UNITS OF EACH OF THE FOLLOWING PRODUCTS: PREMILENE 3/0, 75 CM DS24; PREMILENE 2/0, 75 CM, DS30, PREMILENE 4/0, 75 CM, DS19 AND MONOSYN 3/0, 70 CM, HR22. THE UNITS RECEIVED ARE: 3 UNITS OF MONOSYN, 6 UNITS OF PREMILENE 4/0, 75 CM, DSL9 AND 12 UNITS OF PREMILENE 3/0, 75 CM, DS24. INDIVIDUAL PRODUCTS STOCK AND TRACEABILITY WERE CHECKED AND THEY ARE CORRECT. THE REVIEW OF THE PRODUCT MANUFACTURE DETERMINED THAT TWO SETS WERE MANUFACTURED AT THE SAME TIME FOR THE SAME CUSTOMER. ONE OF THE SETS CONTAINED 12 UNITS OF PREMILENE 3/0 AND IT IS PROBABLE THAT THE OTHER CONTAINS 12 UNITS OF PREMILENE 2/0 INSTEAD OF 6 UNITS OF EACH OF THE PRODUCTS IN BOTH SETS. THIS WAS HUMAN ERROR WHEN PREPARING THE PRODUCT SETS. FINAL CONCLUSION: COMPLAINT IS JUSTIFIED. CORRECTIVE / PREVENTIVE ACTIONS: NOT APPLICABLE. THE PERSONNEL INVOLVED IN THIS ERROR WAS INFORMED.

    Additional Manufacturer Narrative · 1

    MFR SITE EVAL: SAMPLE RECEIVED: 29 UNOPENED AND 6 OPEN POUCHES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. THERE ARE NO UNITS IN STOCK. RECEIVED 36 UNITS FOR ANALYSIS. RECEIVED 29 CLOSED SAMPLES AND 6 OPEN AND MANIPULATED SAMPLES. PERFORMED TIGHTNESS TEST TO THE CLOSED SAMPLES RECEIVED AND THE UNITS ARE TIGHT. TESTED THE KNOT PULL TENSILE STRENGTH OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS FULFILL THE OEM REQUIREMENTS. REVIEWED THE BATCH MFG RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL OEM REQUIREMENTS. FINAL CONCLUSION: COMPLAINT IS NOT JUSTIFIED. CORRECTION/PREVENTIVE ACTIONS: NA.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THE THREADS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521087 NOVOSYN VIOLET 2/0 (3) 70CM HS 23 (M) SUTURES GAM B.BRAUN SURGICAL S.A. B0990045 M150527002

    Patients

    Seq Age Sex Outcome Treatment
    1