MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 1000 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938739

Device Problems Break (1069); Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The events occurred over a period of days in (b)(6) 2020, reported as, in the week of the week of (b)(6) 2020.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the clamp of an unspecified number of 1000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags had an issue when snapping shut; this was further described as ¿with just manual pressure, no tools used, they will snap shut with small plastic pieces falling out¿.The event occurred during compounding in a laminar flow hood when the bulk air is removed, and then clip is actuated to seal bag prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: the lot was manufactured from march 12, 2020 - march 17, 2020.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.During visual inspection of the provided photograph, two cracked off pieces were observed inside the zip lock bag with the clamp.The reported condition was verified.The cause of the condition was due to a supplier issue.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: 1000 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10504677
• MDR Text Key: 206108082
• Report Number: 1416980-2020-05536
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477237
• UDI-Public: (01)00085412477237
• 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: 10/09/2020

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 Expiration Date: 02/28/2023
• Device Catalogue Number: H938739
• Device Lot Number: 60230192
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 09/08/2020
• Supplement Dates Manufacturer Received: 09/25/2020
• Supplement Dates FDA Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1