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 11/18/2019

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 bolts of minibag plus container/vial docking tool was damaged.The user ¿tried to adjust the vial holder component holder of the device but the bolts were on too tight¿ and the bolts were "close to" being "stripped".¿as a result they were not able to adjust the vial holder to use the device¿.This was identified during setup and preparation.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to h3 and h6.H10: the actual device was not available; however, photographs of the sample were provided for evaluation.The returned photographs were reviewed, and it was noted that in one of the photographs the bolts on the docking tool were observed to be stripped out.The reported condition was verified.The cause of the reported condition could not be determined.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: 9476232
• MDR Text Key: 170966617
• Report Number: 1416980-2019-06929
• 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: 01/15/2020

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?: No
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1