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

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

Event Description

It was reported that the non-reopening clamp of an unspecified quantity of 2000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags were difficult to close.It was further reported that the clamps were very tight and difficult to close or clamp shut.Staff members stated that it often required the use of two hands to close the clamp and even then, it was hard to do.This issue was identified during use; however, there was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to h3, h4 and h6.Correction to g1: device manufacturer postal code.H4: the lot was manufactured from may 29, 2020 - may 30, 2020.H10: the actual devices were not available; however, a photograph of the sample was provided for evaluation.A visual inspection of the photograph was performed using the naked eye which did not identify any abnormalities that could have contributed to the reported condition.No clamp damage could be observed.Due to the nature of the sample, no additional testing could be performed.The reported condition was not verified during photo inspection.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: 10468685
• MDR Text Key: 204867072
• Report Number: 1416980-2020-05280
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: H938740
• Device Lot Number: 60242537
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1