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

Catalog Number A4138-17

Device Problem Material Integrity Problem (2978)

Patient Problem Awareness during Anaesthesia (1707)

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

The user facility reported that an epidural catheter was in use with a patient when its plastic sheared off and its internal wiring was exposed.According to the reporter, the catheter was removed normally; it was removed from patient's back by hand.The reporter explained that the patient was provided regional anesthesia as a result of the epidural catheter damage.No permanent injury reported.

• Brand Name: PORTEX CONTINUOUS EPIDURAL
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.,; 10 bowman drive; keene NH 03431 0724
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.,; 10 bowman drive; keene NH 03431 0724
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5551507
• MDR Text Key: 41991341
• Report Number: 2183502-2016-00736
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A4138-17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2016
• 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