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

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.

• 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
• MDR Report Key: 8327008
• MDR Text Key: 135849707
• Report Number: 3012307300-2019-00670
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 30351688059301
• UDI-Public: 30351688059301
• Combination Product (y/n): N
• PMA/PMN Number: E332605
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1