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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC PORTEX ANESTHESIA CONDUCTION KIT

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SMITHS MEDICAL ASD, INC PORTEX ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 100/391/116CZ
Device Problems Material Separation (1562); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/05/2019
Event Type  malfunction  
Event Description
It was reported that the catheter broke during removal. The clinician attempted another space, however the desired length of catheter could not be inserted. The clinician abandoned the procedure as a result. This incident occurred during induction. No patient injury or complications were reported in relation to this event.
 
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Brand NamePORTEX
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC
6000 nathan lane north
minneapolis MN 55442
MDR Report Key8917277
MDR Text Key155101527
Report Number3012307300-2019-04212
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 04/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2021
Device Catalogue Number100/391/116CZ
Device Lot Number3138613
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/09/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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