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

Catalog Number	A2744-17/27
Medical Device Problem Codes	Difficult to Insert (1316); Material Too Rigid or Stiff (1544)
Health Effect - Clinical Codes	Infiltration into Tissue (1931); Perforation (2001)
Date of Event	12/25/2018
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
One epidural catheter and connector were received for evaluation.Upon visual inspection of the flat filter and connector, no discrepancies were noted.Visual inspection of the returned catheter revealed that the tip was bent approximately 5mm from the distal end.However, the catheter tip appeared to be smooth and rounded.All catheter eyes were noted to be present and were properly formed.A dried substance was present throughout the inside of the catheter.As functional testing, attempts were made to push fluid through the catheter/connector assembly (using a fluid filled syringe) to observe for flow from the catheter eyes.This test was not successful due to the dried substance inside the catheter, impeding the flow.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.The cause of the reported issue was not determined.

• Brand Name: PORTEX COMBINED SPINAL EPIDURAL CUSTOM TRAY
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8276016
• Report Number: 3012307300-2019-00365
• Device Sequence Number: 11282933
• Product Code: CAZ
• UDI-Device Identifier: 30351688059301
• UDI-Public: 30351688059301
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2019

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 Expiration Date: 10/01/2020
• Device Catalogue Number: A2744-17/27
• Device Lot Number: 3713218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2018
• Supplement Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1