FDA.reportPublic FDA data

MAUDE MDR 2440620

MDR report key
2440620
Report number
3004590970-2012-00001
Event key
0
Event type
3
Date of event
2011-12-20
Date received
2012-01-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
TRENA DEPEL
Address
1140 MILLENIUM DR. CROWN POINT IN 46307 US
Phone
925-925-9259
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ARCADIA MEDICAL SILICONE CTS TRACHEOSTOMY TUBETRACHEOSTOMY TUBE.ARCADIA MEDICALBTO120-060120-06001103232Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-01-2001. O

Event Narratives#

D

Patient 1

ON (B)(6) 2011, AN ARCADIA MEDICAL SILICONE CTS (CLOSE TO SHAFT) TRACHEOSTOMY TUBE, 6.0 MM ID, WAS SUCCESSFULLY PLACED IN A PT AND THE OBTURATOR REMOVED. SHORTLY AFTER PLACEMENT, A NURSE OBSERVED THE PT BEGIN TO DISPLAY SOME RESPIRATORY DISTRESS. THE PT COUGHED AND EXPELLED A SILICONE TIP THAT HAD BEEN A PART OF THE OBTURATOR COMPONENT OF THE TUBE. THE TRACH TUBE WAS CHANGED AS A PRECAUTION. NO FURTHER INTERVENTION WAS REPORTED. THERE WERE NO REPORTED NEGATIVE PT SEQUELAE. THE PRODUCT WAS RETAINED FOR EVAL.

N

Patient 1

PRIOR TO DEVICE RETURN, THREE (3) UNITS FROM THE SAME LOT NUMBER WERE PULL TESTED FROM THE DISTAL OBTURATOR TIP. ALL FORCES EXCEEDED 25 LBF BEFORE TIPS OR TIP/SLEEVE ASSEMBLIES FAILED. THE RETURNED DEVICE DEMONSTRATED SEPARATION FROM THE DISTAL SILICONE "OLIVE TIP" FROM THE SILICONE SLEEVE. THIS WAS THE RESULT OF INADEQUATE ADHESIVE FROM A MANUAL PROCESS. PREVENTIVE ACTION HAS BEEN INITIATED ON THIS PROCESS. DATE OF THIS REPORT TO FDA: (B)(4) 2012.