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

Catalog Number	A2693-17/27
Medical Device Problem Codes	Product Quality Problem (1506); Failure to Deliver (2338)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.
Event or Problem Description
It was reported that a portex® combined spinal epidural system catheter did not have a hole at the tip and fluid was unable to be delivered.The issue was observed during a spinal attempt during a cesarean section procedure.The device was placed by anesthesia staff.It was observed after the epidural catheter was removed that it was not perforated at the patient end, 1cm from the catheter tip, as expected.General anesthesia was administered to address the epidural issue.The cesarean section was reported to be successful.No injury was reported.See mfr: 3012307300-2017-00634.
Additional Manufacturer Narrative
One used 6ml hypodermic syringe was returned for investigation.The sample was received with a non-smiths medical device assembled to the syringe by a luer connection.The opposite end of the non-smiths medical device was assembled to a portion of the epidural catheter which was approximately 3.5" in length; this portion had been taken from the patient end.Approximately 2.5" of the catheter fragmented protruded from the non-smiths medical device.The catheter fragment was microscopically inspected and it was found that the three eyes, which are typically located at the tip of the patient end, were not present.During functional testing, attempts were made to push fluid through the assembly; however, the fluid was unable to move through.Additionally, attempts to push fluid were made using the smiths epidural connection; the fluid was unable to pass through.Investigation confirmed the reported complaint and determined that the root cause of the event was due to the catheter component which is a supplied item.

• Brand Name: PORTEX® COMBINED SPINAL EPIDURAL SYSTEM
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6354650
• Report Number: 3012307300-2017-00483
• Device Sequence Number: 18933915
• Product Code: CAZ
• UDI-Device Identifier: 30351688058007
• UDI-Public: 30351688058007
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K965017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2017

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: 05/01/2018
• Device Catalogue Number: A2693-17/27
• Device Lot Number: 3318736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2017
• Supplement Report FDA Received Date: 03/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 44 YR