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

Catalog Number EPX1177/118DJP

Device Problems Fluid/Blood Leak (1250); Defective Component (2292)

Patient Problem Pain (1994)

Event Date 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

Possible lot: 180426.Report source: foreign (b)(6).Device evaluation: one flat filter and epifuse connector were returned for investigation.When examining the product, it was confirmed that the base of the male connector of the flat filter was broken and the fractured surface was whitened.The whitening was seen when the plastic material broke due to external load was confirmed in the filter.Therefore, it is possible that the sample was broken by an excessive load on a continuous or instantaneous basis.Based on the investigation, the complaint allegation was confirmed.It was also noted there was a high probably of damage due to the load during use of the product.Therefore, user interface was stated as the problem source.

Event Description

Information was received that the epidural anesthesia filter and epifuse connector from a smiths medical portex epidural custom continuous tray were laid under a patient's body during use.Due to the positioning, it was reported the connection bent and caused medical fluid to leak from it.The patient reported to have complained of pain, but no bleeding was reported.The filter and connector were replaced.No additional adverse patient effects were reported.

• Brand Name: PORTEX EPIDURAL CUSTOM CONTINUOUS TRAY
• 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 NORTH AMERICA; 10 bowman drive; keene NH 03431 0724
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 8724021
• MDR Text Key: 148951898
• Report Number: 3012307300-2019-02720
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EPX1177/118DJP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Date Manufacturer Received: 08/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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