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

Catalog Number H938739

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 12/04/2018

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 two (2) 1000 ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags were leaking from the port.The leaks were discovered during preparation.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information : the lot number was manufactured between april 14, 2018 - april 15, 2018.The actual device was not available; however, photographs were provided for evaluation.Photo inspection was performed and one (1) bag revealed a leak near the administration port.Functional testing was not performed due to the nature of the sample.The reported condition was verified for one (1) sample.The cause of the condition could not be determined.This issue is being further investigated.The second bag was not returned; therefore, a device analysis could not be completed.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 submitted.

Manufacturer Narrative

Two samples were received for evaluation.The bags were sliced at the top left where the customer likely drained the contents.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed which revealed a spike port cap leak from the base of the spike port of both samples.The reported condition was verified.The cause of the reported condition could not be determined.This issue is being further investigated.Should additional relevant information become available, a supplemental report will submitted.

• Brand Name: 1000 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE ¿ ROUND LAKE; round lake IL
• MDR Report Key: 8204182
• MDR Text Key: 131700888
• Report Number: 1416980-2018-08072
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477237
• UDI-Public: (01)00085412477237
• Combination Product (y/n): N
• 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,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: H938739
• Device Lot Number: 60120571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Date Manufacturer Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1