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

Catalog Number EPX1027/118BJP

Device Problems Break (1069); Fluid/Blood Leak (1250); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

Foreign report source: (b)(4).Device evaluation: one epifuse connector was returned to smiths medical for investigation.Upon immediate visual inspection of the connector, it was confirmed that the hinge was damaged.Per the kit manufacturing process, a 100% inspection is performed on the appearance of epifuse connectors before installation.Therefore, it was noted that the hinge part likely was cracked and damaged when using the epifuse connector, but could not be confirmed.The hinge damage confirms the reported complaint allegation.The evaluation noted the problem source of the event as the supplier.

Event Description

Information was received that a smiths medical portex epidural custom continuous tray had medical fluid leaking from the epifuse connector immediately on use.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: 9504025
• MDR Text Key: 177419140
• Report Number: 3012307300-2019-07297
• 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: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: EPX1027/118BJP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2019
• Date Manufacturer Received: 11/22/2019
• 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