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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 01/01/2019
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.
 
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Brand Name
PORTEX COMBINED SPINAL EPIDURAL CUSTOM TRAYS
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL NORTH AMERICA
10 bowman drive
keene NH 03431 0724
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key8328894
MDR Text Key135849573
Report Number3012307300-2019-00674
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier30351688059301
UDI-Public30351688059301
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
E332605
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/11/2019
1 Device was Involved in the Event
1 Patient was 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 Health Professional
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
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/14/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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