MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 2000 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938740

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

Patient Problem No Patient Involvement (2645)

Event Date 08/26/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a 2000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag leaked.The leak was observed from small hole located on the "left side seam on top of the bag between the 600 and 800 markings".The leak was discovered after filling prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to d10, h3, h4 and h6.H4: the lot was manufactured from march 11, 2020 - march 12, 2020.H10: the device was received for evaluation.The bag was marked in the lower left edge and the top right corner was cut where the customer likely drained the contents.Unaided visual inspection was performed which observed a tear at the lower left edge of the bag where the marking was observed.Functional testing was performed which revealed a leak on the marked location.Additional magnified inspection which observed a tear/hole on the location of the leak.The reported condition was verified.The cause of the condition was not 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: 2000 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10567407
• MDR Text Key: 207942133
• Report Number: 1416980-2020-05889
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• 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: H938740
• Device Lot Number: 60231132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1