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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MALLINCRODT; ESOPHAGEAL TRACHEAL TUBE
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COVIDIEN MALLINCRODT; ESOPHAGEAL TRACHEAL TUBE Back to Search Results
Model Number 5-18537
Device Problem Inflation Problem (1310)
Patient Problem No Patient Involvement (2645)
Event Date 09/01/2014
Event Type  malfunction  
Event Description
Covidien received information from a customer stating that during pre-use testing, the cuff on a combitube would not inflate.There was no patient involvement.
 
Manufacturer Narrative
The lot number was asked but unknown.Without the lot number, the date of manufacture cannot be determined.(b)(4).
 
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Brand Name
MALLINCRODT
Type of Device
ESOPHAGEAL TRACHEAL TUBE
Manufacturer (Section D)
COVIDIEN
avenida henequen
1181 parque industrial salvarcar
cd. juarez, chihuahua
MX 
Manufacturer (Section G)
COVIDIEN
avenida henequen
1181 parque industrial salvarcar
cd. juarez, chihuahua
MX  
Manufacturer Contact
denise braxton
6135 gunbarrel ave.
boulder, CO 80301
3038768909
MDR Report Key4113256
MDR Text Key4921658
Report Number2936999-2014-00849
Device Sequence Number1
Product Code CAO
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K875226
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 09/01/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5-18537
Device Catalogue Number5-18537
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/01/2014
Initial Date FDA Received09/24/2014
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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