BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY NEEDLE

    MDR report key: 6666075 · Received June 25, 2017

    Report

    Report Number
    1017768-2017-05094
    Event Type
    Malfunction
    Date Received
    June 25, 2017
    Date of Event
    March 1, 2017
    Report Date
    January 19, 2018
    Manufacturer
    COVIDIEN
    Product Code
    NKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDER WAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THERE WERE NO SAMPLES RECEIVED WITH THIS COMPLAINT THEREFORE AN EXAMINATION OF THE REPORTED CONDITION COULD NOT BE MADE. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT PERFORMED DURING THIS INVESTIGATION AS THE LOT NUMBER WAS NOT RECEIVED WITH THE COMPLAINT. ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY PRIOR TO RELEASE OF PRODUCT. BECAUSE THERE WAS NO LOT NUMBER, A DATE OF MANUFACTURE COULD NOT BE DETERMINED. THE COMPLAINT FILE CONTAINS INSUFFICIENT INFORMATION TO DETERMINE A MOST PROBABLE ROOT CAUSE. SINCE THIS COMPLAINT WILL BE CONSIDERED UNCONFIRMED, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. IF ADDITIONAL INFORMATION OR SAMPLES ARE RECEIVED, THE INVESTIGATION WILL RESUME AS NEEDED. THIS COMPLAINT WILL BE USED FOR TRENDING PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS LOCAL ANESTHETIC LEAKS OUT FROM THE JOINT OF THE SYRINGE LUER SLIP AND MAGELLAN SAFETY NEEDLE DURING INJECTION. ALSO, WHEN TAKING IV BLOOD SAMPLE FOR BLOOD GAS ANALYSIS, SHE HAS NOTED BUBBLES ENTERING THE SYRINGE FROM SEAL OF LUER SLIP AND MAGELLAN NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446601 SAFETY NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN, REPROCESSED NKK COVIDIEN UNK NS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1