BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURSHIELD SAFETY WINGED BLOOD COLLECTION SET

    MDR report key: 3842472 · Received June 2, 2014

    Report

    Report Number
    3004102031-2014-00002
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    April 27, 2014
    Report Date
    June 2, 2014
    Manufacturer
    TERUMO MEDICAL PRODUCTS HANGZHOU
    Product Code
    FPA
    PMA / PMN Number
    K031279
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP # 1 FOR MFG. REPORT # 3004102031-2014-00002 TO PROVIDE THE PATIENT DEMOGRAPHICS THAT WAS INADVERTENTLY NOT PROVIDED IN THE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. THE INVOLVED SAMPLE IS NOT AVAILABLE FOR EVALUATION. THEREFORE, THE INVESTIGATION WAS BASED UPON EVALUATION OF USER FACILITY INFORMATION, RETAINED SAMPLES, AND QUALITY RECORDS. VISUAL INSPECTION OF RETAINED SAMPLES DID NOT REVEAL ANY DEFECTS OR ABNORMALITIES. FUNCTION TESTING ON THE RESERVE SAMPLES CONFIRMED THAT PERFORMANCE SPECIFICATIONS WERE MET. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS FOR THIS LOT NUMBER. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT NUMBER HAS NOT BEEN REPORTED PREVIOUSLY. ALTHOUGH THE CAUSE FOR THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE EVENT WAS RELATED TO A PRE-EXISTING DEVICE DEFECT. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN OCCURRENCE IN THE INSTRUCTIONS-FOR-USE WITH STATEMENTS SUCH AS THE FOLLOWING: "KEEP HANDS BEHIND THE NEEDLE AT ALL TIMES DURING USE AND 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 THE SAFETY FEATURE DID NOT ENGAGE FOLLOWING USE OF THE DEVICE. FOLLOW UP COMMUNICATION REVEALED; (1) THE SAFETY DEVICE REQUIRES EXTRA EFFORT TO ENGAGE THE SAFETY MECHANISM; (2) ONE PARTICULAR TECH INCURRED THREE NEEDLE STICKS AS A RESULT OF REMOVING THE PROTECTOR PRIOR TO MOVING THE SAFETY MECHANISM OUT OF THE WAY FOR INJECTION; AND (3) NO MEDICAL INTERVENTION WAS NEEDED.

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP # 1 FOR MFG. REPORT # 3004102031-2014-00002 TO PROVIDE THE PATIENT DEMOGRAPHICS THAT WAS INADVERTENTLY NOT PROVIDED IN THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321074 SURSHIELD SAFETY WINGED BLOOD COLLECTION SET SAFETY NEEDLE FPA TERUMO MEDICAL PRODUCTS HANGZHOU NA 131010B

    Patients

    Seq Age Sex Outcome Treatment
    1