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
Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
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.It was noted that this device was a backup epidural that was attempted after the first failed attempt.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: 3012307300-2017-00483.

• 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: 6354651
• Report Number: 3012307300-2017-00634
• Device Sequence Number: 18933902
• 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
• Report Date (Section B): 02/17/2017

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2017
• 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