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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOSPIRA LTA 360 KIT LTA KIT

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HOSPIRA LTA 360 KIT LTA KIT Back to Search Results
Lot Number 04-320-RA
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/31/2012
Event Type  malfunction  
Event Description
A distal portion of the laringotracheal anesthesia (lta) injection cannula broke off and it was found in the patient's trachea. Upon retrieval it was noted the edges of the pieces were smooth - clean break.
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Brand NameLTA 360 KIT
Type of DeviceLTA KIT
Manufacturer (Section D)
275 n. field dr.
bldg h2
lake forest IL 60045
MDR Report Key2438494
MDR Text Key19583882
Report Number2438494
Device Sequence Number1
Product Code CCT
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/01/2012
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/01/2012
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number04-320-RA
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/01/2012
Event Location Hospital