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

Catalog Number JC7751

Device Problem Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

This report summarizes 1 malfunction events.A user had difficulty spiking a nacl bag with a y-type blood/solution set.This event occurred before use of the device.There was no patient involvement.No additional information is available.

• Brand Name: 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: 8818480
• MDR Text Key: 152168065
• Report Number: 1416980-2019-03950
• Device Sequence Number: 1
• Product Code: BRZ
• UDI-Device Identifier: 00085412152738
• UDI-Public: (01)00085412152738
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: JC7751
• Device Lot Number: ASKU
• Date Manufacturer Received: 06/30/2019
• Type of Device Usage: N
• Patient Sequence Number: 1