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

Catalog Number 2C4950

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was an issue with a mini-bag plus container/vial docking tool.This issue was further described as, ¿the vial holder on the back is not lined up so something is definitely not aligned correctly¿.It was not specified when in the process step this occurred.There was no patient involvement.No additional information is available.

Manufacturer Narrative

D2a: common device name: equipment, laboratory, general purpose, labeled or promoted for a specific medical use.H10: the actual device was not available; however, photographs of the sample were provided for evaluation.Visual inspection of the photographs was performed using the naked eye which did not identify any abnormalities that could have contributed to the reported condition.All components were correctly placed and according to specifications; no damaged or improperly assembled components were observed.The reported condition was not verified.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
• 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 ; 2242702068
• MDR Report Key: 15545367
• MDR Text Key: 306323361
• Report Number: 1416980-2022-05318
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/09/2022
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: 11/01/2022
• Supplement Dates FDA Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1