BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO HYPODERMIC NEEDLE

    MDR report key: 1884448 · Received October 25, 2010

    Report

    Report Number
    1118880-2010-00019
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 25, 2010
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    FMI
    PMA / PMN Number
    K771203
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS, CONCLUSIONS: ARE BASED ON USER FACILITY INFO; IN REFERENCE TO THE UNUSED RETURNED & RESERVE SAMPLES TESTED. THE INVOLVED DEVICE IS NOT AVAILABLE FOR EVAL. AN UNUSED SAMPLE WAS RETURNED BY THE USER FACILITY FOR EVAL. THE RETURNED UNUSED SAMPLE PLUS RETAINED SAMPLES FROM THE REPORTED LOT, THE PREVIOUS AND SUBSEQUENT LOTS WERE VISUALLY EXAMINED AND TESTED FOR BOTH RETENTION FORCE OF THE NEEDLE CANNULA TO THE HUB AND FOR BREAKAGE OF THE STEEL CANNULA ACCORDING TO ISO (B)(4). NO DEFECTS WERE OBSERVED. IN ADDITION, ALL SAMPLES TESTED WERE CONFIRMED TO MEET THE PERFORMANCE SPECS FOR BOTH JOINT STRENGTH AND FOR RESISTANCE TO BREAKAGE. THE DEVICE HISTORY RECORD DID NOT INDICATE ANY PRODUCTION RELATED PROBLEMS. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT HAS NOT BEEN REPORTED PREVIOUSLY. ALTHOUGH THE CAUSE FOR THE REPORTED SEPARATION OF THE NEEDLE FROM THE HUB CANNOT BE DEFINITIVELY DETERMINED BASED UPON THE AVAILABLE INFO, THERE IS NO INDICATION THAT THE EVENT WAS RELATED TO A PRE-EXISTING DEVICE DEFECT. ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QA AT THE MFG FACILITY FOR APPROPRIATE TRACKING, TRENDING AND F/U. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE NEEDLE BECAME DETACHED WHILE ADMINISTERING AN INJECTION. ADD'L INFO THAT WAS PROVIDED BY THE USER FACILITY INCLUDED THE FOLLOWING: THE PHYSICIAN WAS INJECTING MEDICATION IN THE UTERINE CERVIX TO ESTABLISH A PARA-CERVICAL BLOCK; THE METAL NEEDLE BECAME DETACHED FROM THE PLASTIC HUB DURING THE INJECTION; THE PROCEDURE WAS ABORTED AND THE PT WAS TRANSPORTED TO THE HOSPITAL FOR EVAL; IMAGING CONFIRMED THAT THE NEEDLE WAS EMBEDDED IN THE CERVIX; SUBSEQUENTLY, THE DETACHED NEEDLE WAS REMOVED BY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO HYPODERMIC NEEDLE FMI TERUMO MEDICAL CORP. NA LP1625

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention 10CC SYRINGE