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 catheter fragment was removed from the patient by hand, with no further intervention needed.No further adverse effects to patient reported.

• 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; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: michele seliga ; 1265 grey fox road; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5480485
• MDR Text Key: 39681088
• Report Number: 2183502-2016-00418
• 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
• 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