MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 4000 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938742

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that 4 4000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags leaked from the administration port; further described as a loose connector.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.H10:the actual device was not available; however, a photograph of the sample was provided for evaluation.  visual inspection was performed to the photograph using the naked eye which revealed that the administration port was leaking.The reported condition was verified.  by the nature of the sample, no additional tests were performed.  the cause of the condition could not be determined.  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: 4000 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10225250
• MDR Text Key: 197351793
• Report Number: 1416980-2020-03736
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477268
• UDI-Public: (01)00085412477268
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: H938742
• Device Lot Number: 60147016
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1