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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 TRAYS ANESTHESIA CONDUCTION KIT

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SMITHS MEDICAL ASD, INC. PORTEX COMBINED SPINAL EPIDURAL CUSTOM TRAYS ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number A2744-17/27
Device Problem Difficult to Insert (1316)
Patient Problems Infiltration into Tissue (1931); Perforation (2001)
Event Date 01/14/2019
Event Type  malfunction  
Event Description
Information was received that a smiths medical portex combined spinal epidural custom tray went "intravascularly" on the patient. No additional adverse patient effects were reported.
 
Manufacturer Narrative
Device evaluation: one used and decontaminated epidural catheter assembled to an epidural catheter connector and a flat filter were returned for evaluation. Visual inspection of the flat filter and connector, found them to be in good physical condition. Visual inspection of the returned catheter revealed that the tip appeared to be smooth and rounded. All catheter eyes were present and were properly formed. A dried substance was noted throughout the inside of the catheter; preventing further visual inspection. Attempts were made to remove the catheter from the connector to allow further dimensional testing, but were unsuccessful. Functional testing included testing for proper fit using the corresponding epidural needle for the returned kit. The distal tip of the catheter passed through the hub of the needle until it passed through the bevel tip; a slight resistance was noted. The results were found to be acceptable. 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. Conclusively, the investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.
 
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Brand NamePORTEX COMBINED SPINAL EPIDURAL CUSTOM TRAYS
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key8327008
MDR Text Key135849707
Report Number3012307300-2019-00670
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
E332605
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 09/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberA2744-17/27
Device Catalogue NumberA2744-17/27
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2019
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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