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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 A3169-17/27
Device Problem Leak/Splash (1354)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 01/10/2019
Event Type  malfunction  
Manufacturer Narrative
Evaluation results: one used and decontaminated epidural catheter (part number ca046) assembled to an epidural catheter connector (part number cp1690) was received for investigation without its original packaging visual inspection of the returned catheter revealed that the distal tip was bent approximately 5 mm from the tip. It also revealed what appeared to be a slice through the catheter tubing on one side. This damage was located approximately 6 inches from the proximal (connector) end. Leakage from the damaged area was confirmed when tested with a water filled syringe. While the damage to the catheter was confirmed it could not be determined with any certainty at what point the damage occurred.
 
Event Description
It was reported that the epidural catheter was inserted uneventfully and bolused via the catheter; and subsequently placed on an infusion. When the healthcare provider was called in to provide additional medication, the catheter had developed a "leak" approximately 6 inches from the distal connector, hence not allowing more medication to be given (it was spewing onto her bed). The patient was pushing and the healthcare provider was unable to perform another epidural at that point. No patient injury or further 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
Manufacturer (Section G)
SMITHS MEDICAL, ASD INC.
10 bowman drive
keene NH 03431 0724
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key9184108
MDR Text Key173730192
Report Number3012307300-2019-05510
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 10/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/01/2020
Device Catalogue NumberA3169-17/27
Device Lot Number3705544
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/26/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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