BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUR-VET SYRINGE

    MDR report key: 2033496 · Received March 23, 2011

    Report

    Report Number
    3003902955-2011-00004
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    TERUMO (PHILIPPINES) CORPORATION
    Product Code
    FMF
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS REPORT WAS NOT ASSOCIATED WITH A HUMAN PT. RESULTS AND CONCLUSIONS: ARE BASED UPON RETURNED SAMPLE EVALUATION; IS BASED UPON RESERVE SAMPLE EVALUATION. VISUAL EXAMINATION OF THE RETURNED SAMPLE DETERMINED THAT THERE IS VISIBLE EVIDENCE OF SIGNIFICANT BENDING OF NEEDLE, BOTH WITHIN THE CANNULA MOUND (PROXIMAL END) AND THE DETACHED DISTAL PORTION. THE CANNULA WAS SEVERELY BENT IN ONE DIRECTION, WHICH WAS SUFFICIENT TO CAUSE KINKING OF THE CANNULA SHAFT AS EVIDENCED BY THE PROFILE OF THE EXTERIOR SURFACE AND DISTORTION OF THE LUMEN TO AN IRREGULAR OVAL SHAPE. MICROSCOPIC EXAMINATION SHOWS EVIDENCE THAT THE NEEDLE WAS THEN BENT BACK IN THE OPPOSITE DIRECTION AT WHICH TIME THE DISTAL PORTION BECAME DETACHED. INSPECTION AND TESTING OF RETAINED SAMPLES CONFIRMED THAT THERE WERE NO DEFECTS AND PRODUCT 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 HAS NOT BEEN REPORTED PREVIOUSLY. ALTHOUGH THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED, THE RETURNED SAMPLE APPEARANCE IS CONSISTENT WITH REPEATED OR EXCESSIVE BENDING OF THE CANNULA DURING USE. ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MFG FACILITY FOR TRACKING, TRENDING, AND F/U. NOTE: ALTHOUGH THIS REPORT IS RELATED TO A HYPODERMIC SYRINGE WITH NEEDLE PRODUCT THAT IS LABELED FOR USE IN THE VETERINARY MARKET, THE PRODUCT IS IDENTICAL TO HYPODERMIC SYRINGE WITH NEEDLE PRODUCT THAT IS LABELED FOR HUMAN USE. THEREFORE, THIS REPORT IS BEING SUBMITTED AS A PRECAUTIONARY MEASURE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY (AN ANIMAL HOSP) REPORTED THAT A HYPODERMIC NEEDLE "BROKE" WHILE THE TECHNICIAN WAS DRAWING BLOOD AT THE NECK DURING A PROCEDURE TO NEUTER A CANINE. F/U COMMUNICATION WITH PERSONNEL AT THE FACILITY CONFIRMED: AFTER THE REPORTED BREAKAGE, A CUT DOWN PROCEDURE WAS PERFORMED; THE DETACHED DISTAL PIECE OF THE NEEDLE WAS SUCCESSFULLY RETRIEVED; AND THE ORIGINAL SURGICAL PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUR-VET SYRINGE FMF TERUMO (PHILIPPINES) CORPORATION NA 101015S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA