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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX DISPOSABLE ANESTHESIA CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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SMITHS MEDICAL ASD; INC. PORTEX DISPOSABLE ANESTHESIA CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Catalog Number C37101329-NLJ
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/01/2020
Event Type  malfunction  
Event Description
Information was received indicating that immediately starting to use a smiths medical portex® disposable anesthesia circuit, air was noted leaking from it.There were no reported adverse patient effects.
 
Manufacturer Narrative
Device evaluation: one smiths medical portex general anesthesia circuit was returned for analysis in a used condition.Visual inspection was performed, and embedded resin was found on the tube.During analysis, the returned sample did not pass a leak test.Based on the evidence, the complaint was confirmed, and the problem source of the reported event was noted to be manufacturing.
 
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Brand Name
PORTEX DISPOSABLE ANESTHESIA CIRCUITS
Type of Device
CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section D)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis,, mn
MDR Report Key9857794
MDR Text Key184247778
Report Number3012307300-2020-02144
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date09/17/2022
Device Catalogue NumberC37101329-NLJ
Device Lot Number3878463
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2020
Date Manufacturer Received04/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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