BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONODEK ABSORBABLE SUTURE

    MDR report key: 1731702 · Received June 9, 2010

    Report

    Report Number
    3004365956-2010-00073
    Event Type
    Malfunction
    Date Received
    June 9, 2010
    Date of Event
    May 12, 2010
    Report Date
    May 17, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL - METHOD: DEVICE HISTORY REVIEW - BASED ON THE FACT, THE LOT NUMBER PROVIDED IS INVALID, THE MOST RECENT DEVICE HISTORY REVIEW FOR LOT NUMBER (02D1002488) BUILT ON (B)(4) 2010 WAS REVIEWED. RESULTS: IN THE DEVICE HISTORY REVIEW, NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THE REPORTED COMPLAINT ISSUE. CONCLUSIONS: NO ROOT CAUSE CAN BE DETERMINED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING A PROCEDURE, THE TECHNICIAN ATTEMPTED TO LOAD THE MONODEK ABSORBABLE SUTURE INTO THE CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE. HOWEVER, DURING THE PLACEMENT OF THE 1/2 CIRCLE TAPER NEEDLE INTO THE HEAD OF THE CAPIO DEVICE, THE NEEDLE DETACHED. THE NEEDLE DETACHED OUTSIDE OF THE PATIENT. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONODEK ABSORBABLE SUTURE ABSORBABLE SUTURE GAK TELEFLEX MEDICAL NA 0003578760

    Patients

    Seq Age Sex Outcome Treatment
    1