BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMARTIP MED-PREP CANNULA

    MDR report key: 1713278 · Received June 3, 2010

    Report

    Report Number
    1017768-2010-00009
    Event Type
    Other
    Date Received
    June 3, 2010
    Date of Event
    April 23, 2010
    Report Date
    May 4, 2010
    Manufacturer
    COVIDIEN
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2010. AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2010 BY BAXTER HEALTHCARE THAT A PT EXPERIENCED AN ADVERSE EVENT WHILE USING THE SMARTIP NEEDLESS VIAL ACCESS CANNULA. CUSTOMER REPORTS THAT THE RUBBER STOPPER OF THE BAXTER CONTINU-FLO SOLUTION SET SEEMS TO BE RESISTING WHEN THE COVIDIEN SMARTIP NEEDLESS VIAL ACCESS IS INSERTED. THE RUBBER STOPPER IS PUSHED INTO THE TUBING, FLUIDS DRAIN OUT OF THE PORT AND THE TUBING CAN NO LONGER BE USED. THIS OCCURRED WHILE A PT WAS IN THE OPERATING ROOM. HIS HEART RATE DROPPED VERY LOW AND NEW TUBING WAS HUNG. ADDITIONAL INFO WAS RECEIVED BY COVIDIEN BY CONTACTING THE USER FACILITY DIRECTLY WHO REPORTED THAT THE PT WAS UNDERGOING AN EYE PROCEDURE AND WHEN THIS TYPE OF PROCEDURE IS BEING PERFORMED, THE PT'S HEART RATE WILL TYPICALLY DROP AND THEREFORE THEY INJECT MEDICATION TO KEEP THE HEART RATE UP. THE CUSTOMER STATED THAT THEY INJECTED MEDICATION USING THE SMARTIP INTO THE RUBBER STOPPER OF THE TUBING SET. THE TUBING STOPPER PUSHED IN, LOSS OF MEDICATION OCCURRED AND THE PT'S HEART RATE HAD DROPPED INTO THE 40'S. THE CUSTOMER ALSO STATED FOLLOWING THE INCIDENT, THE PT DID RECEIVE THE APPROPRIATE MEDICATION AND HIS HEART RATE RETURNED TO NORMAL. THERE WAS NO FURTHER INTERVENTION REQUIRED. THE REPORTED EVENT WAS NOT A RESULT OF THE COVIDIEN PRODUCT MALFUNCTIONING. THE MONOJECT SMARTIP IS A NEEDLELESS VIAL ACCESS ONLY CANNULA WHICH HAD BEEN USED INCORRECTLY WITH A CONTINU-FLO IV SOLUTION SET. THE MALFUNCTION OCCURRED WITH ANOTHER MFR'S CONTINU-FLO IV SOLUTION SET. THE COVIDIEN SALES PERSON CONTACTED THE USER FACILITY DIRECTLY ON (B)(4) 2010 AND RECEIVED ADDITIONAL INFO REGARDING THE USE OF THE COVIDIEN SMARTIP. THE CUSTOMER HAD STATED THAT THEY HAVE NOT BEEN EXPERIENCING ISSUES WITH THE COVIDIEN SMARTIP BUT WITH ANOTHER MFR'S CONTINU-FLO SOLUTION SET. THE CUSTOMER HAD ALSO STATED THAT THEY ARE AWARE THAT THE SMARTIP SHOULD NOT BE INJECTED INTO THE PORTS AND IS FOR VIAL ACCESS, BUT HAD BEEN DOING SO TEMPORARILY WHILE THEY IDENTIFY ANOTHER TYPE OF TUBING SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTIP MED-PREP CANNULA VIAL ACCESS ONLY NEEDLESS CANNULA FPA COVIDIEN 8881540111 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other