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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 12/05/2018
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 was returned for evaluation. Upon visual inspection, device was found to have smooth, round tip as well as catheter eyes were present and properly formed. A dried substance was noted to be present throughout the inside of the catheter. As functional testing, attempts were made to push fluid through the catheter after assembling it to a connector to observe for flow from the catheter eyes. This test was not successful due to the dried substance inside the catheter which impeded flow, confirming the reported customer complaint. The returned catheter was also tested for proper fit. 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. 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 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 Key8276018
MDR Text Key134064128
Report Number3012307300-2019-00364
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 Date10/01/2019
Device Catalogue NumberA2744-17/27
Device Lot Number3692809
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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