MAUDE Adverse Event Report: BAXTER HEALTHCARE - CLEVELAND MINIBAG PLUS CONTAINER; SEE H10

Catalog Number 2C4950

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Common device name: equipment, laboratory, general purpose, labeled or promoted for a specific medical use.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; 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.It was reported that rust was observed on a mini-bag plus container/vial docking tool during compounding.There was no patient involvement.No additional information is available.

• Brand Name: MINIBAG PLUS CONTAINER
• Type of Device: SEE H10
• Manufacturer (Section D): BAXTER HEALTHCARE - CLEVELAND; cleveland MS
• Manufacturer (Section G): BAXTER HEALTHCARE - CLEVELAND; 911 highway 61 north; po box 1058; cleveland MS 38732
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8283739
• MDR Text Key: 134444946
• Report Number: 1416980-2019-00331
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 01/28/2019

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?: No
• Device Operator: No Information
• Device Catalogue Number: 2C4950
• Device Lot Number: GD898916
• Initial Date Manufacturer Received: 12/31/2018
• Initial Date FDA Received: 01/28/2019
• Type of Device Usage: N
• Patient Sequence Number: 1