BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL ACTION KIT: ED THORACOTOMY INST.

    MDR report key: 5311105 · Received December 18, 2015

    Report

    Report Number
    1030451-2015-00005
    Event Type
    Malfunction
    Date Received
    December 18, 2015
    Date of Event
    November 17, 2015
    Report Date
    December 18, 2015
    Manufacturer
    MEDICAL ACTION INDUSTRIES
    Product Code
    KDD
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS KELLY FORCEP ((B)(4)) IS INCLUDED IN THE MEDICAL ACTION INDUSTRIES MANUFACTURED CONVENIENCE KIT, 80381 KIT: ED THORACOTOMY INSTRUMENT. THIS COMPONENT HOWEVER IS MANUFACTURED BY THE SUPPLIER GLOBAL INSTRUMENTS INCORPORATED. A SUPPLIER CORRECTIVE ACTION REQUEST WAS FORWARDED TO THE SUPPLIER ON (B)(6) 2015 FOR INCIDENT INVESTIGATION. GLOBAL INSTRUMENTS INCORPORATED HAS REVIEWED A PHOTOGRAPH OF THE INSTRUMENT BREAKAGE AND APPROPRIATELY INVESTIGATED THE MANUFACTURING OF THE INSTRUMENT INVOLVED. THEY HAVE CONCLUDED THAT THE RESULTING DEFECT MAY HAVE BEEN THE RESULT OF THE OIL HEAT TREATMENT USED ON THIS PRODUCT (THIS IS ONE OF THE MANY STEPS IN THE MANUFACTURING PROCESS). THE MANUFACTURER HAS RESPONDED THAT THEY WILL CHANGE THIS OIL HEAT TREATMENT TO A MORE ADVANCED AND PRECISE GAS HEAT TREATMENT WHICH WILL RESULT IN STRONGER INSTRUMENT CONSTRUCTION. THIS CORRECTIVE ACTION WAS IMPLEMENTED ON 12/03/2015. MEDICAL ACTION INDUSTRIES EVALUATES EACH PRODUCT COMPLAINT FOR ANY RELATED PRODUCT TRENDS. WE HAVE FOUND NO TRENDS RELATED TO THIS PRODUCT COMPLAINT. THIS PARTICULAR INSTRUMENT AND ISSUE APPEARS TO BE ISOLATED WITHIN OUR COMPLAINT DATABASE AS WE HAVE RECEIVED NO SIMILAR COMPLAINTS FOR THIS INSTRUMENT.

    Description of Event or Problem · 1

    MEDICAL ACTION INDUSTRIES IS THE MANUFACTURER OF A CONVENIENCE KIT THAT CONTAINS A KELLY FORCEP MANUFACTURED BY GLOBAL INSTRUMENTS INC. MEDICAL ACTION RECEIVED INCIDENT COMPLAINT FROM END USER, (B)(6) HOSPITAL, ON (B)(6) 2015. A TRAUMA PATIENT WAS HAVING A CHEST TUBE PLACED WHEN THE KELLY FORCEP BROKE WHILE A RESIDENT WAS HOLDING THE CHEST TUBE. THE HOSPITAL DIRECTOR OF EMERGENCY SERVICES HAS CONFIRMED THAT THIS INCIDENT DID NOT RESULT IN ANY PATIENT INJURY OR ANY ADDITIONAL DIAGNOSTIC IMAGING OR INTERVENTIONS. MEDICAL ACTION INDUSTRIES IS THE MANUFACTURER OF A CONVENIENCE KIT (KIT: ED THORACOTOMY INSTRUMENT) THAT CONTAINS THE KELLY FORCEP ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838528 MEDICAL ACTION KIT: ED THORACOTOMY INST. ED THORACOTOMY INSTRUMENT CONVENIENCE KIT KDD MEDICAL ACTION INDUSTRIES 80381 211980

    Patients

    Seq Age Sex Outcome Treatment
    1