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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC PORTEX; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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SMITHS MEDICAL ASD, INC PORTEX; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Model Number C49291785D-NL
Device Problems Crack (1135); Disconnection (1171); Fluid/Blood Leak (1250)
Patient Problem No Information (3190)
Event Date 05/26/2017
Event Type  malfunction  
Event Description
The elbow connection of the circuit is cracking and causing a large leak intra-operatively.Our facility has experienced several similar issues with this particular device.Also, we are experiencing numerous disconnects (from the looser fittings) and persistent leaks around the swivel connector at the gas sampling line connector.Note: the device is manufactured by portex, distributed by (b)(4), and packaged in (b)(4).Manufacturer response for disposable anesthesia breathing circuit, disposable anesthesia breathing circuit (per site reporter).Unknown at the time of this report.
 
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Brand Name
PORTEX
Type of Device
CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC
10 bowman drive
keene NH 03431
MDR Report Key6604098
MDR Text Key76395641
Report Number6604098
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2017
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberC49291785D-NL
Device Catalogue NumberC49291785D-NL
Device Lot Number3360701
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/31/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer05/31/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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