BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN SYRINGE

    MDR report key: 2052404 · Received March 17, 2011

    Report

    Report Number
    1118880-2011-00004
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Report Date
    February 15, 2011
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    FMF
    PMA / PMN Number
    K822083
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: ARE BASED UPON USER INFORMATION ONLY SINCE THE INVOLVED SAMPLE WAS NOT RETURNED FOR EVALUATION; IS BASED UPON TESTING OF RESERVE SAMPLES. CONCLUSIONS: IS BASED UPON USER INFORMATION ONLY SINCE THE INVOLVED SAMPLE WAS NOT RETURNED FOR EVALUATION; IS BASED UPON TESTING OF RESERVE SAMPLES. NEITHER SPECIFIC INFORMATION REGARDING THE CONDITIONS UNDER WHICH THE REPORTED PROBLEM OCCURRED NOR THE INVOLVED DEVICE IS AVAILABLE FOR EVALUATION. EVALUATION OF SAMPLES FROM THE REPORTED LOT, THE PREVIOUS AND SUBSEQUENT LOTS DID NOT REVEAL ANY ABNORMALITIES. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT NUMBER HAS NOT BEEN REPORTED PREVIOUSLY. ALTHOUGH THE CAUSE FOR THE REPORTED BREAKAGE CANNOT BE DEFINITIVELY DETERMINED BASED UPON THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE EVENT WAS RELATED TO A PRE-EXISTING DEVICE DEFECT. THE FACT THAT THIS WAS A SELF-INJECTION BY A LAY USER IN A NEEDLE EXCHANGE PROGRAM MAY BE A CONTRIBUTING FACTOR. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4).

    Description of Event or Problem · 1

    A PARTICIPANT IN A NEEDLE EXCHANGE PROGRAM REPORTED THAT AN INSULIN SYRINGE NEEDLE "BROKE OFF" WHILE ATTEMPTING TO INJECT HIMSELF/HERSELF. FOLLOW-UP COMMUNICATION WITH PERSONNEL AT THE NEEDLE EXCHANGE FACILITY CONFIRMED: THE USER WAS A LAYPERSON THAT WAS INJECTING ILLICIT DRUGS; THEY DID NOT REQUIRE MEDICAL ATTENTION AS A RESULT OF THE REPORTED BREAKAGE OF THE NEEDLE; AND ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSULIN SYRINGE FMF TERUMO MEDICAL CORP. NA LM2137

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK