MAUDE Adverse Event Report: CAREFUSION 211, INC.. DBA CAREFUSION CAREFUSION PCA TUBING; TUBING, FLUID DELIVERY

Lot Number 11611800

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 11/03/2016

Event Type  malfunction  

Event Description

Patients iv tubing found to be leaking.Assessed tubing and determined that it was the pca tubing leaking.Crack found in hard plastic connector end of tube.

• Brand Name: CAREFUSION PCA TUBING
• Type of Device: TUBING, FLUID DELIVERY
• Manufacturer (Section D): CAREFUSION 211, INC.. DBA CAREFUSION; 22745 savi ranch pkwy.; yorba linda CA 92887
• MDR Report Key: 6331500
• MDR Text Key: 67565858
• Report Number: 6331500
• Device Sequence Number: 1
• Product Code: FPK
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 11611800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/10/2016
• Event Location: Other
• Date Report to Manufacturer: 11/10/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR