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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL CATHETER ANESTHESIA CONDUCTION KIT Back to Search Results
Device Problems Difficult to Insert (1316); Material Too Rigid or Stiff (1544)
Patient Problems Infiltration into Tissue (1931); Perforation (2001)
Event Type  malfunction  
Manufacturer Narrative
Date of event : possible event date (b)(6) 2018.
 
Event Description
Information was received that a smiths medical portex epidural catheter was too stiff, causing vascular penetration. No additional adverse patient effects were reported.
 
Manufacturer Narrative
One catheter was returned for evaluation. Upon visual inspection, it was found to be in good physical condition. It was noted a dried substance was present throughout the inside of the catheter. As functional testing, attempts were made to push fluid through the catheter/connector assembly (using a fluid filled syringe) to observe for flow from the catheter eyes. This test was not successful due to the dried substance inside the catheter which impeded flow. The distal tip of the catheter was passed through the hub of the needle until it passed through the bevel tip. A slight resistance was observed as the tip of the catheter emerged from the bevel of the needle. However, this is considered to be an acceptable fit. The reported customer complaint was unable to be confirmed. While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.
 
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Brand NamePORTEX EPIDURAL CATHETER
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key8276020
MDR Text Key134063764
Report Number3012307300-2019-00368
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 company representative,user f
Type of Report Initial,Followup
Report Date 03/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2019
Is This a Reprocessed and Reused Single-Use Device? No

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