BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN VIOLET 4/0 (1,5) 70 HR26 (M).

    MDR report key: 3970073 · Received April 28, 2014

    Report

    Report Number
    2916714-2014-00309
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 28, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAM
    PMA / PMN Number
    K011375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 1 BOX LABELED AS G0022024, BATCH (B)(4) BUT PRODUCT INSIDE IS G0022016 (NOT G0022014 AS INFORMED BY THE CUSTOMER) WITH THE SAME BATCH 113394, WE HAVE RECEIVED ALL 12 UNITS WITH THE SAME REFERENCE BATCH. THERE ARE TWO PREVIOUS COMPLAINTS OF THIS CODE BATCH FOR THIS SAME ISSUE. INSIDE MONOSYN PRE-PRINTED BOX LABELED AS MONOSYN REF.(B)(4) (MONOSYN 4/0 70CM HR26) AND BATCH (B)(4) THERE IS IN FACT MONOSYN REF. (B)(4) MONOSYN 2/0 70CM HR22), WITH THE SAME BATCH 113394. THIS MIX-UP HAS BEEN PRODUCED IN THE MANUFACTURING LIE AT THE MOMENT OF PACKAGING THE PRODUCT. BOTH ARTICLES WERE PACKED IN THE SAME LINE AND SAME DAY. LINE CLEARANCE WAS NOT PERFORMED CORRECTLY. FINAL CONCLUSION: THE COMPLAINT IS CORRESPONDING (JUSTIFIED). CORRECTIVE/PREVENTIVE ACTIONS: OEM HAS OPENED A CORRECTIVE ACTION IN ORDER TO AVOID THIS KIND OF INCIDENTS IN THE FUTURE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). PACKAGE LABELED AS G0022024ESV MONOSYN VIOLET 4/0 (1,5) 70 HR26 (M) DDP. LOT 113394 BIT CONTINUING G0022014ESV - MONOSYN VIOLET 4/0 (1,5) 70 HR22 (M) DD LOT. 113394.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253565 MONOSYN VIOLET 4/0 (1,5) 70 HR26 (M). SYNTHETIC ABSORBABLE SUTURE GAM B. BRAUN SURGICAL S.A. G0022024ESV 113394

    Patients

    Seq Age Sex Outcome Treatment
    1