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

Catalog Number 2C4950

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

Common device name - equipment, laboratory, general purpose, labeled or promoted for a specific medical use should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that mini-bag plus container/vial docking tool was damaged.The docking tool was being used to attach the mini-bag to the vial and it was observed that the gears were stripped and would not allow the push to attach the vial to the bag.Neither the bag nor vial were damaged, and the customer was not able to adjust the apparatus that would reengage the tool.This event was observed during setup/preparation.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The actual sample was received for evaluation.A visual inspection was performed, and it was noted that all components were on the tool as required and had been assembled properly.However, damage was observed on the gears, screws, vial adaptor nest, vial holding jaws, and several pieces of the complaint sample that are attached to the slip clutch.The gears, screws, nests, jaws and mechanical function pieces were observed to be rusted and covered in a dried fluid substance.An actual functional test using vials was not performed; however, the docking tool was tested.It was observed that the gears were stripped thus not allowing force to be applied.The reported condition was verified.The cause of the reported condition could not be determined.The potential root cause of the issue is the product was exposed to a solution containing sodium potentially during use.Since the docking tool was not cleaned (as evident) after use, rust formed on the gears from and parts of the tool, thus causing degradation of the metal and stripping of the gears.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: MINIBAG PLUS CONTAINER
• Type of Device: SEE H10
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9406377
• MDR Text Key: 169077587
• Report Number: 1416980-2019-06661
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/03/2020

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: Other
• Device Catalogue Number: 2C4950
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 12/03/2019
• Supplement Dates Manufacturer Received: 12/20/2019
• Supplement Dates FDA Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1