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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX COMBINED SPINAL EPIDURAL CUSTOM TRAY ANESTHESIA CONDUCTION KIT

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SMITHS MEDICAL ASD, INC. PORTEX COMBINED SPINAL EPIDURAL CUSTOM TRAY ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number A2744-17/27
Device Problems Difficult to Insert (1316); Material Too Rigid or Stiff (1544)
Patient Problems Infiltration into Tissue (1931); Perforation (2001)
Event Date 12/25/2018
Event Type  malfunction  
Event Description
Information was received that a smiths medical portex combined spinal epidural custom tray was too stiff, causing vascular penetration. No additional adverse patient effects were reported.
 
Manufacturer Narrative
One epidural catheter and connector were received for evaluation. Upon visual inspection of the flat filter and connector, no discrepancies were noted. Visual inspection of the returned catheter revealed that the tip was bent approximately 5mm from the distal end. However, the catheter tip appeared to be smooth and rounded. All catheter eyes were noted to be present and were properly formed. 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, impeding the flow. The presence of the dried substance may support the customer's claim for the occurrence of an intravascular penetration. However, the returned catheter was found to be within specification and was fully formed with a smooth, rounded tip. The cause of the reported issue was not determined.
 
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Brand NamePORTEX COMBINED SPINAL EPIDURAL CUSTOM TRAY
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key8276016
MDR Text Key134063527
Report Number3012307300-2019-00365
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 03/19/2019
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
Device Expiration Date10/01/2020
Device Catalogue NumberA2744-17/27
Device Lot Number3713218
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2019
Is This a Reprocessed and Reused Single-Use Device? No

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