BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GARG

    MDR report key: 1673809 · Received April 24, 2010

    Report

    Report Number
    1320894-2010-00054
    Event Type
    Injury
    Date Received
    April 24, 2010
    Report Date
    April 23, 2010
    Manufacturer
    CONMED CORPORATION
    Product Code
    KDQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG DOCUMENTS FROM THE DHR/LHR FOR LOT 0810031 HAS VERIFIED THE DEVICES WERE PRODUCED ACCORDING TO CURRENT AND APPROVED PROCEDURES AND MATERIAL SPECIFICATIONS. NON-CONFORMANCES REGARDING THE PRODUCT'S IDENTITY, QUALITY, SAFETY, EFFECTIVENESS OR PERFORMANCE WERE NOT IDENTIFIED DURING MANUFACTURE. NO LABORATORY EXAMINATION WAS PERFORMED ON THE COMPLAINT PRODUCTS, AS NO DEVICES WERE MADE AVAILABLE. COMPLAINT HISTORY HAS SHOWN SIMILAR COMPLAINTS, HOWEVER, WITHOUT THE DEVICE WE CANNOT CONFIRM ANY MFG DEFECTS. THERE MAY BE A MULTIPLE OF POSSIBLE CAUSES, EITHER MFG OR USER RELATED, FOR THIS COMPLAINT. THE COMPLAINT CAN BE NEITHER CONFIRMED NOR UNCONFIRMED AT THIS TIME. IF THE PRODUCT IS RETURNED IN THE FUTURE, THE COMPLAINT WILL BE RE-OPENED AND A FURTHER INVESTIGATION WILL BE PERFORMED. NO CORRECTIVE ACTION CAN BE RECOMMENDED AT THIS TIME. WE ARE CONSIDERING THIS COMPLAINT CLOSED. THIS REPORT IS LINKED TO THE FOLLOWING MEDWATCHES: 1320894-2010-00046; -00055; AND -00056.

    Description of Event or Problem · 1

    IT WAS REPORTED, "FOUR DIFFERENT NEEDLES, SAME PT WERE USED AND LEAKED. THE PT HAD TO HAVE A CHEST TUBE PLACED IN CHEST." CAT. #THR-1720. THIS OCCURRED OVER THE WEEKEND OF (B) (6) 2010, END-USER DID NOT HAVE THE EXACT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GARG THORACENTESIS NEEDLE KDQ CONMED CORPORATION NA 0810031

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention