MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC CLEARLINK BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION

Catalog Number 2C8750

Device Problems Fluid/Blood Leak (1250); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

This report summarizes 1 malfunction events.It was reported that the spike of a clearlink y-type blood/solution set was difficult to remove from the bag, resulting in a blood leak once removed.This event involved a patient with no patient consequences.No additional information is available.

Manufacturer Narrative

The device was not returned and the provided lot number was not recognized by baxter; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK BLOOD RECIPIENT SET
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; haina, san cristobal
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina san cristobal ; DR
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8000714
• MDR Text Key: 124982022
• Report Number: 1416980-2018-06747
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 2C8750
• Device Lot Number: DR1D04061
• Date Manufacturer Received: 12/31/2018
• Type of Device Usage: N
• Patient Sequence Number: 1