MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL MEDEX HIGH PRESSURE TUBING; CONNECTOR, BLOOD TUBING, INFUSION T

Catalog Number MX693P1CZ

Device Problems Leak/Splash (1354); Inadequate User Interface (2958)

Patient Problem No Information (3190)

Event Date 10/02/2019

Event Type  malfunction  

Event Description

Information was received stating smiths medical medex high pressure tubing has failed, dispersing blood/fluid.No adverse effects reported.

Manufacturer Narrative

Additional information was received from the customer indicting the cause of fault was due to a handling issue and that there was no product problem.

• Brand Name: SMITHS MEDICAL MEDEX HIGH PRESSURE TUBING
• Type of Device: CONNECTOR, BLOOD TUBING, INFUSION T
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• MDR Report Key: 9194167
• MDR Text Key: 167785457
• Report Number: 3012307300-2019-05751
• Device Sequence Number: 1
• Product Code: FKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MX693P1CZ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1