MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. NON DEHP T-CONNECTOR EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number UR17E26047

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 09/22/2018

Event Type  malfunction  

Event Description

Injection port of t-connector became non-occlusive and turned within the plastic.T-connector changed.Infant lost approximately 45 ml of blood.Infant required increased monitoring.

• Brand Name: NON DEHP T-CONNECTOR EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 7929466
• MDR Text Key: 122469922
• Report Number: 7929466
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UR17E26047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 365 DA
• Patient Weight: 5