MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 2000 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938740

Device Problem Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The event occurred on unspecified date of (b)(6) 2020.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that ten (10) 2000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags had issues with the clamps that will not close and when they do close, they then pop off.This was identified prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to h3, h4 and h6.H4: the lot was manufactured from may 22, 2020 - may 23, 2020.H10: the actual samples were not available and therefore could not be evaluated; however, one (1) companion sample was received for evaluation.Unaided visual inspection did not identify any abnormalities that could have contributed to the reported condition.The clamp was evaluated which observed that it took excessive force to snap and shut the clamp and the clamp remained closed.The reported condition was verified.The cause of the condition is a manufacturing related issue.This issue is being further investigated.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: 2000 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10623477
• MDR Text Key: 209771645
• Report Number: 1416980-2020-06167
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477244
• UDI-Public: (01)00085412477244
• Combination Product (y/n): Y
• PMA/PMN Number: K900585
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: H938740
• Device Lot Number: 60241405
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1