BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXEL 3CC DISPOSABLE LUER LOCK SYRINGE W NEEDLE 22GX3/4"

    MDR report key: 7054363 · Received November 22, 2017

    Report

    Report Number
    1035907-2017-00001
    Event Type
    Malfunction
    Date Received
    November 22, 2017
    Date of Event
    August 18, 2017
    Report Date
    November 21, 2017
    Manufacturer
    EXELINT INTERNATIONAL, CO.
    Product Code
    FMF
    UDI-DI
    00020221261158
    PMA / PMN Number
    K861153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS FOR HUMAN USE AND NOT LABELED FOR VETERINARY USE. IT IS UNKNOWN WHETHER THE USE ON ANIMALS MAY RESULT IN STRESSES OR CONDITIONS THAT ARE EXCEED THOSE THAT WOULD BE EXPECTED DURING USE ON HUMANS. THIS IS EXELINT INTERNATIONAL'S FIRST ELECTRONIC REPORT AND IT IS DELAYED DUE TO THE SIGN UP PROCESS FOR THE WEB TRADER ACCOUNT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING TEST RECORD INDICATED THAT NEEDLE CANNULA WAS TESTED FOR BENDING AND BREAKAGE RESISTANCE AND ALL TEST RESULTS ARE IN COMPLIANCE WITH ISO 9626. THE INVESTIGATION CONTINUED ON AFFECTED SAMPLE WHEN RECEIVED. A VISUAL INSPECTION OF THE COMPLAINT SAMPLE IDENTIFIED THAT PART OF THE NEEDLE CANNULA REMAINED INSIDE THE NEEDLE HUB, INDICATING MATERIAL, NOT BOND FAILURE. THE SURFACE OF THE BROKEN NEEDLE CANNULA WAS NOT FLAT/SMOOTH, SUGGESTING THAT THE BREAKAGE WAS CAUSED BY A SINGLE STRONG EXTERNAL FORCE BEYOND THE DESIGN SPECIFICATIONS FOR THIS GAUGE STAINLESS STEEL NEEDLE. THE INVESTIGATION INDICATES THAT THE BREAKAGE OF THE NEEDLE WAS CAUSED BY A STRONG EXTERNAL BENDING FORCE THAT EXCEEDED THE DESIGN SPECIFICATIONS OF THIS GAUGE NEEDLE STAINLESS STEEL NEEDLE AND WAS NOT DUE TO A PRODUCT DEFECT.

    Description of Event or Problem · 1

    THE DOG (CANINE, (B)(6))) WAS INJECTED SUBCUTANEOUSLY WHILE RESTRAINED BY A VETERINARY TECHNICIAN. DURING THE INJECTION, THE NEEDLE BROKE OFF THE HUB AND BECAME LODGED UNDER THE SKIN. THE ATTENDING DVM PLACED THE DOG UNDER GENERAL ANESTHESIA AND SURGICALLY REMOVED THE NEEDLE.

    Description of Event or Problem · 1

    THE DOG (CANINE, SIBERIAN HUSKY MIX)) WAS INJECTED SUBCUTANEOUSLY WHILE RESTRAINED BY A VETERINARY TECHNICIAN. DURING THE INJECTION, THE NEEDLE BROKE OFF THE HUB AND BECAME LODGED UNDER THE SKIN. THE ATTENDING DVM PLACED THE DOG UNDER GENERAL ANESTHESIA AND SURGICALLY REMOVED THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834212 EXEL 3CC DISPOSABLE LUER LOCK SYRINGE W NEEDLE 22GX3/4" DISPOSABLE SYRINGE FMF EXELINT INTERNATIONAL, CO. 26115 160802 00020221261158

    Patients

    Seq Age Sex Outcome Treatment
    1 19 WK