MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC PORTEX; ANESTHESIA CONDUCTION KIT

Catalog Number A3169-17/27

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation results: one used and decontaminated epidural catheter (ca046) assembled to an epidural catheter connector (cp1690) was returned with its original packaging.Visual inspection of the returned catheter revealed that the distal tip was bent approximately 5 mm from the tip.  it also revealed what appeared to be a slice through the catheter tubing on one side.  this damage was located approximately 6 inches from the proximal (connector) end.Leakage from the damaged area was confirmed when tested with a water filled syringe.The customer stated that the catheter was "inserted uneventfully" and bolused via the catheter" indicating that the catheter initially functioned as intended.While the damage to the catheter was confirmed it could not be determined with any certainty at what point the damage occurred.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event. a definitive root cause for the product problem could not be established.

Event Description

It was reported that the epidural catheter was inserted uneventfully and bolused via the catheter; and subsequently placed on an infusion.When the healthcare provider attempted to provide additional medication, they noticed that the catheter had developed a "leak" approximately 6 inches from the distal connector, hence preventing the delivery of the medication.The medication had spewed onto the patient's bed.Another epidural could not be delivered at that point because the patient "was pushing (delivering)." no patient injury or further complications were reported in relation to this event.

• Brand Name: PORTEX
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL, ASD INC.; 10 bowman drive; keene NH 03431 0724
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 9147659
• MDR Text Key: 166647808
• Report Number: 3012307300-2019-05486
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/02/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Catalogue Number: A3169-17/27
• Device Lot Number: 3705544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 10/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1