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

Catalog Number	A3947-17
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a piece of a portex® continous epidural catheter broke off, requiring the patient to go to surgery to have it removed.It was noted that the epidural was placed with ease, 10cm at skin.With test dose, there was noted skin elevation and expansion of subcutaneous tissue.Attempt at pulling back the catheter was met with some resistance.Fulling pulling caused break of casing and unspooling of the epidural catheter (fractured catheter).The patient went to surgery to have the fragment removed.After the surgery, the patient was reported as doing fine.No permanent injury was reported.
Event or Problem Description
A ct of lumbar spinal without contrast revealed there was a break within the metallic epidural catheter at the skin surface at the l2 level.The metallic catheter demonstrated an abrupt reduction in caliber along the undersurface of the l2 spinous process.The relatively faint and narrowed catheter extended into the dorsal epidural space at l2-l3.Punctate epidural and neural foraminal air density extended from t12-l1 through l3-l4.Position and alignment of the lumbosacral spine was unremarkable.Mild posterior disc bulge at l5-s1 without nerve root compression or displacement.Mild diffuse posterior disc bulge at l4-l5 without nerve root compression or displacement.The l3-l4 disc is unremarkable.

• Brand Name: PORTEX® CONTINOUS EPIDURAL
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7209421
• Report Number: 3012307300-2018-00077
• Device Sequence Number: 1185332
• Product Code: CAZ
• UDI-Device Identifier: 20351688079494
• UDI-Public: 20351688079494
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Expiration Date: 11/01/2018
• Device Catalogue Number: A3947-17
• Device Lot Number: 3360737
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2018
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 01/22/2018
• Supplement Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIDOCAINE HCL 1%; LIDOCAN 1.5%/EPINFRN; POVIDONE IODINE; SOD.CHORIDE 0.9%
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Weight: 73