BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO NEOLUS NEEDLE

    MDR report key: 2992148 · Received March 7, 2013

    Report

    Report Number
    1118880-2013-00009
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    FMI
    PMA / PMN Number
    K771203
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO RETRIEVE THE DETACHED NEEDLE, BUT THERE IS NO CODE AVAILABLE. RESULTS = BASED ON EVALUATION OF USER FACILITY INFORMATION & THE RETURNED SAMPLE; BASED ON EVALUATION OF RESERVE SAMPLES. CONCLUSIONS = EVALUATION OF USER FACILITY INFORMATION & THE RETURNED SAMPLE; EVALUATION OF RESERVE SAMPLES. VISUAL EXAMINATION OF THE RETURNED SAMPLE DETERMINED THAT THE DISTAL PORTION OF THE STEEL CANNULA HAD BEEN BROKEN AT THE POINT WHERE IT IS BONDED BY EPOXY TO THE LUER HUB AND THAT THE PROXIMAL PORTION OF THE CANNULA WAS STILL ATTACHED TO THE LUER HUB. MAGNIFIED INSPECTION OF THE EDGE OF THE CANNULA & THE EPOXY SURROUNDING THE POINT OF SEPARATION SHOWED EVIDENCE THAT IS CONSISTENT WITH THE NEEDLE HAVE BEEN SEVERELY BENT PRIOR TO BREAKING. INSPECTION OF RETAINED SAMPLES FROM THE REPORTED LOT, THE PREVIOUSLY MANUFACTURED LOT AND THE SUBSEQUENTLY MANUFACTURED LOT CONFIRMED THAT THERE WERE NO DEFECTS OR ANOMALIES. TESTING OF RETAINED SAMPLES FROM THE REPORTED LOT, THE PREVIOUSLY MANUFACTURED LOT AND THE SUBSEQUENTLY MANUFACTURED LOT CONFIRMED THAT PRODUCT PERFORMANCE SPECIFICATIONS WERE MET FOR STIFFNESS AND RESISTANCE TO BREAKAGE IN ACCORDANCE WITH ISO 9626. 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. THERE IS NO INDICATION THAT THE EVENT WAS RELATED TO A PRE-EXISTING DEVICE DEFECT. ALTHOUGH THE CAUSE FOR THE OBSERVED BREAKAGE OF THE NEEDLE CANNULA CANNOT BE DEFINITIVELY DETERMINED BASED UPON THE AVAILABLE INFORMATION, THE APPEARANCE OF THE RETURNED SAMPLE IS MOST CONSISTENT WITH THE NEEDLE HAVE BEEN SEVERELY BENT PRIOR TO BREAKING. 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

    THE USER FACILITY REPORTED THAT THE NEEDLE BECAME DETACHED WHILE ADMINISTERING AN INJECTION. ADDITIONAL INFORMATION THAT WAS PROVIDED BY THE USER FACILITY INCLUDED THE FOLLOWING: A PORTION OF THE METAL NEEDLE REPORTEDLY BECAME DETACHED FROM THE PLASTIC HUB WHILE THE PHYSICIAN WAS INJECTING A LOCAL ANESTHETIC IN THE UTERINE CERVIX; THE LOCATION OF THE DETACHED PORTION OF THE NEEDLE WAS THEN DETERMINED BY CT SCAN; AND THE PATIENT WAS TAKEN TO THE OR WHERE THE DETACHED PORTION OF THE NEEDLE WAS SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97347 TERUMO NEOLUS NEEDLE HYPODERMIC NEEDLE FMI TERUMO MEDICAL CORPORATION NA MP0825

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention