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

Model Number	A2744-17/27
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	Infiltration into Tissue (1931); Perforation (2001)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Event or Problem 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.

• Brand Name: PORTEX COMBINED SPINAL EPIDURAL CUSTOM TRAYS
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8328894
• Report Number: 3012307300-2019-00674
• Device Sequence Number: 2284867
• Product Code: CAZ
• UDI-Device Identifier: 30351688059301
• UDI-Public: 30351688059301
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: E332605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A2744-17/27
• Device Catalogue Number: A2744-17/27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1