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 04/23/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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.The handle broke off during bag assembly prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to d9, h3 and h6.H10: the device was received for evaluation.A visual inspection was performed, and it was noted that there was damage to the docking tool handle; further described as, the handle was missing from the piston.The reported condition was verified.The cause of the 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: EQUIPMENT, LABORATORY, GENERAL PURPOS, LABELED OR PROMOTED FOR A SPECIFIC MEDIC
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11844527
• MDR Text Key: 254527880
• Report Number: 1416980-2021-03034
• Device Sequence Number: 1
• Product Code: LXG
• 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: 06/17/2021

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: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 05/18/2021
• Supplement Dates Manufacturer Received: 06/09/2021
• Supplement Dates FDA Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.