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	12/05/2018
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 was returned for evaluation.Upon visual inspection, device was found to have smooth, round tip as well as catheter eyes were present and properly formed.A dried substance was noted to be present throughout the inside of the catheter.As functional testing, attempts were made to push fluid through the catheter after assembling it to a connector to observe for flow from the catheter eyes.This test was not successful due to the dried substance inside the catheter which impeded flow, confirming the reported customer complaint.The returned catheter was also tested for proper fit.The distal tip of the catheter was passed through the hub of the needle until it passed through the bevel tip.A slight resistance was observed as the tip of the catheter emerged from the bevel of the needle.However, this is considered to be an acceptable fit.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• 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: 8276018
• Report Number: 3012307300-2019-00364
• Device Sequence Number: 1557397
• 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: 10/01/2019
• Device Catalogue Number: A2744-17/27
• Device Lot Number: 3692809
• 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