BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO SURGUARD2 SAFETY NEEDLE

    MDR report key: 2072582 · Received April 21, 2011

    Report

    Report Number
    3003902955-2011-00005
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    TERUMO PHILIPPINES CORPORATION
    Product Code
    FMI
    PMA / PMN Number
    K051865
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE NOT RETURNED FOR EVALUATION, REVIEW OF INFORMATION PROVIDED BY USER FACILITY. RESULTS: ARE BASED UPON EVALUATION OF USER FACILITY INFORMATION. CONCLUSION: IS BASED UPON EVALUATION OF USER FACILITY INFORMATION. THE INVOLVED SAMPLE IS NOT AVAILABLE FOR EVALUATION. THEREFORE, THE INVESTIGATION WAS BASED UPON ASSESSMENT OF USER FACILITY INFORMATION. ALTHOUGH THE CAUSE CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A PRE-EXISTING DEVICE DEFECT. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN OCCURRENCE IN THE WARNINGS/CAUTIONS AND THE INSTRUCTIONS-FOR-USE WITH STATEMENTS SUCH AS THE FOLLOWING : "HANDLE WITH CARE TO AVOID NEEDLESTICKS"; "IF NEEDLE IS BENT OR DAMAGED, NO ATTEMPT SHOULD BE MADE TO STRAIGHTEN NEEDLE OR USE THE PRODUCT"; "POSITION THE SHEATH APPROXIMATELY 45 DEGREES TO FLAT SURFACE. PRESS DOWN WITH A FIRM, QUICK, MOTION UNTIL A DISTINCT AUDIBLE CLICK IS HEARD. VISUALLY CONFIRM THAT THE NEEDLE IS FULLY ENGAGED UNDER THE LOCK"; "DISPOSE OF USED NEEDLES AND MATERIALS FOLLOWING THE POLICIES AND PROCEDURES OF YOUR FACILITY AS WELL AS FEDERAL AND LOCAL REGULATIONS FOR SHARPS DISPOSAL." ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A NURSE WAS UNABLE TO ENGAGE THE SAFETY SHEATH OVER THE NEEDLE AFTER AN INJECTION. THE FOLLOWING INFORMATION WAS OBTAINED: A NURSE WAS ATTEMPTING TO ENGAGE THE SAFETY SHEATH OVER THE NEEDLE BY APPLYING PRESSURE ON A COUNTER TOP; THE CONTACT WITH THE SAFETY SHEATH CAUSED THE NEEDLE TO BEND TO THE LEFT; AFTER THE NEEDLE BECAME BENT, THE NURSE WAS UNABLE TO PROPERLY ACTIVATE SAFETY DEVICE; AND THE ENTIRE DEVICE WAS THEN DISCARDED DIRECTLY INTO A SHARPS CONTAINER WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO SURGUARD2 SAFETY NEEDLE FMI TERUMO PHILIPPINES CORPORATION NA 100614

    Patients

    Seq Age Sex Outcome Treatment
    1 NA