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	01/14/2019
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.
Additional 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
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8327008
• Report Number: 3012307300-2019-00670
• Device Sequence Number: 19404325
• 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,Followup
• Report Date (Section B): 09/20/2019

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
• Supplement Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1