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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL TUSCH EB ROBERTSHAW RIGTH, 39F; ENDOBRONCHIAL TUBE
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TELEFLEX MEDICAL TUSCH EB ROBERTSHAW RIGTH, 39F; ENDOBRONCHIAL TUBE Back to Search Results
Catalog Number 116200390
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/18/2013
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges that after intubation and inflation of the balloon, it was noted to have an insufficient seal.The tube was removed and it was noted that only one side of the balloon was inflated.Another device was inserted with no issues.Consequence: increase intervention time.The patient condition is reported as fine.
 
Manufacturer Narrative
The device sample was not returned for evaluation at the time of this report.
 
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Brand Name
TUSCH EB ROBERTSHAW RIGTH, 39F
Type of Device
ENDOBRONCHIAL TUBE
Manufacturer (Section D)
TELEFLEX MEDICAL
perak
MY 
Manufacturer (Section G)
TELEFLEX MEDICAL
p.o. box 28
34600 kamunting,
perak
MY  
Manufacturer Contact
margie burton, rn
p.o. box 12600
durham, NC 27709
9194334965
MDR Report Key3703023
MDR Text Key15205567
Report Number8040412-2014-00008
Device Sequence Number1
Product Code JOH
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 12/23/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number116200390
Device Lot Number13GT29
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received12/23/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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