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

Catalog Number H938740

Device Problem Fluid/Blood Leak (1250)

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 two (2) 2000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags were leaking from the middle port seam (back of bag).The leaks were identified during setup/preparation prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: device manufactured between may 30, 2020 to june 04, 2020.H10: only one (1) actual sample was received for evaluation, therefore, the other actual sample could not be evaluated.Additionally one (1) companion sample was received and evaluated.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed which revealed a leak at the spike port bonding area in back of the bag with the actual sample and the companion sample.The leak was observed between the spike port tube and the spike port bonding area in back of the bag with both samples.The reported condition was verified.The cause was not determined; however the most likely cause was due to inadequate or lack of cyclohexanone being applied to the cap tubing when it was inserted to the spike port during the manufacturing process.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: 10631242
• MDR Text Key: 209953609
• Report Number: 1416980-2020-06195
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• 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: 60244070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1