MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SET, I.V. FLUID TRANSFER

Catalog Number ASKU

Device Problem Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the clamp of an unspecified quantity of eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags were difficult to close.These issues were identified during setup, and preparation prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to h6.H10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NI
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10627346
• MDR Text Key: 209804611
• Report Number: 1416980-2020-06174
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): Y
• PMA/PMN Number: NI
• 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: 11/02/2020

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: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 10/05/2020
• Supplement Dates Manufacturer Received: 10/07/2020
• Supplement Dates FDA Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1