MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTRAVIA CONTAINER 150ML; CONTAINER, I.V.

Model Number N/A

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 02/16/2014

Event Type  malfunction  

Event Description

Rn went to unspike used antibiotic bag from the secondary iv line and a piece of the antibiotic bag broke off the bag and stayed attached to the spike of the secondary tubing.

• Brand Name: INTRAVIA CONTAINER 150ML
• Type of Device: CONTAINER, I.V.
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 3873859
• MDR Text Key: 19716784
• Report Number: 3873859
• Device Sequence Number: 1
• Product Code: KPE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: N/A
• Device Catalogue Number: 2B8011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/29/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2014
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.
• Patient Age: 15 YR
• Patient Weight: 44