MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 56X030

Device Problems Leak/Splash (1354); Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/26/2018

Event Type  malfunction  

Event Description

Bedside rn reported the following: while reviewing pca settings, rn noted large pool of liquid in pca pump casing and on floor.Upon further investigation, rn noted a split in the pca tubing.

• Brand Name: CADD EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 1265 grey fox rd; saint paul MN 55112
• MDR Report Key: 7356684
• MDR Text Key: 103017355
• Report Number: 7356684
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2018,03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/01/2021
• Device Lot Number: 56X030
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT KNOWN.
• Patient Age: 38 YR