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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INT'AIR MEDICAL SMOOTHBORE CIRC NEO 120CM2WT ELB T20 CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

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INT'AIR MEDICAL SMOOTHBORE CIRC NEO 120CM2WT ELB T20 CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Catalog Number L1202CNT20
Device Problem Disconnection (1171)
Patient Problem Low Oxygen Saturation (2477)
Event Date 03/23/2018
Event Type  Injury  
Manufacturer Narrative
At this time, vyaire has confirmed that the actual device was disposed of. If additional information becomes available, it will be submitted in a follow up report.
 
Event Description
Customer reported an incident with a (b)(6) male patient that was intubated and equipped for surgery. During surgery the patient was changed from a dorsal decubitus position to a left lateral decubitus position. The patient experienced rapid desaturation. The end-user believed that the problem was with the endotracheal tube (ett). The end-user thought the tube was misplaced or dislodged. Therefore, the patient was reintubated. The end-user then noted the disconnection at the level of the y 1 of 2 branches had been disconnected. The circuit that failed was discarded. To date the patient is doing very well.
 
Manufacturer Narrative
The supplier laboratory received the suspect product for investigation. An investigation was performed and the most likely cause of this disconnection was determined to be the presence of moisture in the connectors after injection. This issue will be internally investigated within vyaire.
 
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Brand NameSMOOTHBORE CIRC NEO 120CM2WT ELB T20
Type of DeviceCIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section D)
INT'AIR MEDICAL
2 bis rue des ormeaux
bourg en bresse 1000
FR 1000
Manufacturer (Section G)
INT'AIR MEDICAL
2 bis rue des ormeaux
1000
bourg en bresse
FR
Manufacturer Contact
kristin graf
22745 savi ranch parkway
yorba linda, CA 92887
MDR Report Key7469681
MDR Text Key106779705
Report Number2050001-2018-00100
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberL1202CNT20
Device Lot Number127268
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/27/2018 Patient Sequence Number: 1
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