MAUDE Adverse Event Report: BAXTER HEALTHCARE - HAINA MICRO-VOLUME EXTENSION SET; FILTER, INFUSION LINE

Catalog Number 2N3342

Device Problem Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Manufacturer Narrative

The single-use device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Leak testing and clear passage testing were performed with no issues noted.The device was found to flow normally with no defects or leaks observed.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

This report summarizes 1 malfunction events.It was reported that a micro-volume extension set leaked during infusion.The event involved a patient with no patient consequences.No additional information is available.

• Brand Name: MICRO-VOLUME EXTENSION SET
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): BAXTER HEALTHCARE - HAINA; haina san cristobal
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8287444
• MDR Text Key: 134462649
• Report Number: 1416980-2019-00366
• Device Sequence Number: 1
• Product Code: FPB
• UDI-Device Identifier: 00085412004778
• UDI-Public: (01)00085412004778
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 2N3342
• Device Lot Number: DR18I06024
• Date Manufacturer Received: 12/31/2018
• Type of Device Usage: N
• Patient Sequence Number: 1