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

Catalog Number 100/391/118CZ

Device Problem Break (1069)

Patient Problems Awareness during Anaesthesia (1707); Device Embedded In Tissue or Plaque (3165)

Event Date 03/24/2016

Event Type  malfunction  

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

User facility reported that the listed epidural catheter was in use following a surgical procedure when the epidural catheter was found severed outside the patient's body.The patient's doctor removed and re-affixed the epi-fuse connector to the remaining portion of catheter and used the catheter for another day.The following day, the catheter was found severed again.The epidural catheter was therefore removed from use.The patient reportedly experienced an increase in pain due to the decreased delivery of analgesia.However, no further adverse effects to patient were reported.

Manufacturer Narrative

An epifuse¿ catheter connector and epidural flat filter were returned for investigation.A yellow tube that was not from the original epidural minipak was also returned.All samples arrived without their original packaging.The reported epidural catheter was not sent.Visual investigation found the samples to be in good condition without any abnormalities or defects.No sharp edges were found on the epifuse¿ catheter connector.The blue rubber material of the connector was removed and examined for traces of the severed epidural catheter, none were found.Since the reported epidural catheter was not returned and the epifuse¿ connector showed no traces of the severed connector, the reported issue could not be confirmed.

• Brand Name: PORTEX® EPIDURAL MINIPACK
• 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: 5625426
• MDR Text Key: 44343713
• Report Number: 2183502-2016-00875
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K965017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/391/118CZ
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 11 YR