BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN VIOLET 4/0 (1.5) 8X45CM HR22TO (M)

    MDR report key: 3810524 · Received April 16, 2014

    Report

    Report Number
    2916714-2014-00258
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 6, 2014
    Report Date
    April 16, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAM
    PMA / PMN Number
    K011375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. EVAL: EVAL ON-GOING AT MFG SITE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). AFTER A SURGERY, THE CUSTOMER FOUND THAT THERE WERE 7 NEEDLES WERE PACKED IN A PACKAGE. (ONE NEEDLE WAS MISSING). THE CUSTOMER HAS BEEN INSISTING FOLLOWINGS: "8" SPONGE-CUBES ARE ATTACHED TO COMPLAINT PRODUCT. "9" SPONGE-CUBES ARE ATTACHED TO REFERENCE SAMPLE. GLUE CAN BE OBSERVED ON THE SURFACE OF THE PLACE, WHERE SPONGE-CUBES ATTACHED, WHEN SPONGE-CUBE HAS BEEN REMOVED BY FORCE. THERE IS NO GLUE ON COMPLAINT PRODUCT (BESIDE OF "8"). THEREFORE, ONLY 7 NEEDLES WERE PACKED IN THE COMPLAINT PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233425 MONOSYN VIOLET 4/0 (1.5) 8X45CM HR22TO (M) SYNTHETIC ABSORBABLE SUTURE GAM B. BRAUN SURGICAL S.A. M0022695 113384

    Patients

    Seq Age Sex Outcome Treatment
    1 Other