MAUDE Adverse Event Report: SMITHS MEDICAL PORTEX CONTINUOUS EPIDURAL; ANESTHESIA CONDUCTION KIT

Model Number N/A

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and 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 Description

User facility reported that during use of product for epidural anesthesia, the epidural catheter severed and a portion of the catheter remained in the patient's skin.The user facility reported that that catheter fragment was removed from the patient by hand, with no further intervention needed.No further adverse effects to patient reported.

Manufacturer Narrative

One used catheter with an attached connector was returned for product investigation.The catheter was found damaged and stretched.The physical damage of the catheter is consistent with stress being applied to the catheter; for example, the catheter may have been pulled back through the epidural needle during use.Device literature warns against this type of device handling as the epidural needle is capable of shearing the catheter, and force only 1/3 of a pound is necessary to remove an epidural catheter when patient is positioned correctly.The exact cause of the damaged catheter was not confirmed during device evaluation; however, there was not mounting evidence to suggest it was related to a manufacturing issue.

• Brand Name: PORTEX CONTINUOUS EPIDURAL
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.,; 10 bowman drive; keene NH 03431 0724
• Manufacturer Contact: michele seliga ; 6000 nathan lane n.; minneapolis, MN 55442 ; 7633833052
• MDR Report Key: 5480793
• MDR Text Key: 39696336
• Report Number: 2183502-2016-00417
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K965017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: A4138-17
• Device Lot Number: ASKU
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other