MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 500 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938738

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a 500ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag was leaking from an unspecified location.The leak was identified during setup/preparation 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: device manufactured between february 11, 2020 to february 12, 2020.H10: the device was received for evaluation.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.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: 500 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10627403
• MDR Text Key: 209803940
• Report Number: 1416980-2020-06175
• 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: 11/05/2020

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: 01/31/2023
• Device Catalogue Number: H938738
• Device Lot Number: 60226707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1