MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 250 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938737

Device Problems Fluid/Blood Leak (1250); Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

Medwatch report number: mw509739.The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the clamp of a 250ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag was difficult to close which resulted in a leak from the port.This issue was identified during setup/preparation prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: the lot was manufactured from may 25, 2020 - may 26, 2020.H10: the device was received for evaluation.Unaided visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing using tap water to fill bag, was performed and no leaks were noted.The reported condition was not verified.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: 250 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10541195
• MDR Text Key: 207159434
• Report Number: 1416980-2020-05739
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477213
• UDI-Public: (01)00085412477213
• 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: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: H938737
• Device Lot Number: 60242178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 09/22/2020
• Supplement Dates FDA Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1