BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRIPPER PLUS SAFETY NEEDLE

    MDR report key: 1882634 · Received October 22, 2010

    Report

    Report Number
    2183502-2010-00482
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    August 9, 2003
    Report Date
    October 21, 2010
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    FPA
    PMA / PMN Number
    K021999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    VOLUNTARY REPORT WAS RECEIVED VIA THE US MAIL. THE COVER PAGE FOR THE REPORT STATED: THE ATTACHED REPORT, (B)(6), WAS RECEIVED THROUGH FDA'S MEDWATCH PROGRAM. WE ARE FORWARDING IT TO YOU FOR REVIEW SINCE YOU MIGHT BE UNAWARE OF THIS EVENT. THE REPORT CONTAINS ALL THE INFORMATION PRESENTLY AVAILABLE. THE ATTACHED MAUDE EVENT REPORT (FOI) HAD EXTREMELY LIMITED INFORMATION. INCLUDED WAS AN EVENT DATE OF (B)(6) 2010, A REPORT DATE OF (B)(6) 2010, THE EVENT REPORT TYPE WAS MALFUNCTION, REPORTER OCCUPATION WAS OTHER, THE DEVICE OPERATOR WAS HEALTH PROFESSIONAL. THE REPORTER WAS NOT IDENTIFIED; AS SUCH THE INITIAL REPORTER WAS UNABLE TO BE CONTACTED FOR FURTHER INFORMATION OR DEVICE AVAILABILITY. THE FULL EVENT DESCRIPTION IS RECORDED ON THIS FORM AS B5. THE IDENTIFICATION OF THE DEVICE WAS CATALOG NUMBER 21-2966-24. THE LOT NUMBER WAS LISTED AS 202X30. THIS INFORMATION WAS ENTERED INTO THE MANUFACTURER'S COMPLAINT DATABASE FOR TRACKING AND REPORTING PURPOSES. THIS COMPLAINT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    RECEIVED NOTICE FROM FDA REGARDING AN INCIDENT. NO USER FACILITY INFORMATION WAS INCLUDED WITH THE NOTICE. EVENT DESCRIPTION IS AS FOLLOWS: VOLUN (B)(6) 2010: ON (B) (6) 2010, A HUBER NEEDLE BROKE OFF IN A PATIENT'S CHEST. THE HUBER NEEDLE WAS PLACED IN PATIENT'S CHEST AT (B)(6) CLINIC AT (B)(6) MEDICAL CENTER - (B)(6) CANCER CENTER PLACED BY DR (B)(6) CLINIC. DATE OF INSERTION (B)(6) 2010 AT 9:10 AM. GRIPPER PLUS NON CORING SAFETY NEEDLE MANUFACTURER SMITHS MEDICAL MD INC. LOT/BATCH 202X30 REF/CATALOG 21-2966-24. DATES OF USE: (B)(6) 2010 -- (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRIPPER PLUS SAFETY NEEDLE FPA - SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL MD (FORMERLY DELTEC, INC) 21-2966 202X30

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK