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

Catalog Number H938739

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

The device was manufactured at one of the following manufacturing locations: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a 1000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag leaked at the port.This was further described as, ¿the pharmacy technician transferred diluent into the container through the port using a transfer set.The port was punctured once with a needle.The port which was punctured with the needle leaked during administration to the patient¿.As a result, the registered nurse did an assessment of how much dose was lost and the pharmacy remade a partial dose to be administered to the patient.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information was added to h3 and h6.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph was performed which observed a leak from the bottom of the add port.The reported condition was verified.The cause of the condition could not be determined.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: 10885825
• MDR Text Key: 217708890
• Report Number: 1416980-2020-07299
• Device Sequence Number: 1
• Product Code: LHI
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: H938739
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1