MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MINIBAG PLUS CONTAINER; EQUIPMENT, LABORATORY, GENERAL PURPOS, LABELED OR PROMOTED FOR A SPECIFIC MEDIC

Catalog Number 2C4950

Device Problem Break (1069)

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

Event Date 05/25/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the handle of a mini-bag plus docking assist tool broke off.This was observed prior to use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: the lot was manufactured from april 20, 2020 - april 21, 2020.H10: the device was received for evaluation.A visual inspection was performed using the naked eye which revealed that the handle was missing from the piston.The reported condition was verified.The cause of the condition is manufacturing related.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.

• Brand Name: MINIBAG PLUS CONTAINER
• Type of Device: EQUIPMENT, LABORATORY, GENERAL PURPOS, LABELED OR PROMOTED FOR A SPECIFIC MEDIC
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12027956
• MDR Text Key: 260465809
• Report Number: 1416980-2021-03762
• Device Sequence Number: 1
• Product Code: LXG
• UDI-Device Identifier: 05413765002687
• UDI-Public: (01)05413765002687
• Combination Product (y/n): Y
• 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: 07/19/2021

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: GD908290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 06/18/2021
• Supplement Dates Manufacturer Received: 07/08/2021
• Supplement Dates FDA Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1