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

Catalog Number EPX1401/118JP

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2018

Event Type  malfunction  

Manufacturer Narrative

Report source: (b)(6).Device evaluation: the catheter, connector, and third-party injector was returned for evaluation.Although the syringe was connected to the connector and liquid was passed, the investigation found that no liquid leakage occurred from the components or connection site.In addition, liquid was passed through each component, but no liquid leakage was observed.Product dimensions were checked using an inspection gauge suitable for the inner and outer diameters of each connector, and it was determined that the connectors conformed to the standard and no abnormalities were found.Based on the investigation, the complaint allegation could not be confirmed.No fault was found with the device.

Event Description

Information was received that during the use of a smiths medical portex epidural custom continuous tray, the customer noticed medical fluid was leaking from "the part where the catheter connector and a third party's injector were connected".There were no adverse patient effects.

• 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: 8895321
• MDR Text Key: 154925518
• Report Number: 3012307300-2019-04047
• 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: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: EPX1401/118JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 08/14/2019
• 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