MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 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 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).Initial reporter postal code: (b)(6).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 from an unspecified location.It was further reported that approximately 10ml was observed in the outer bag upon opening the overpouch.The bag contained synthamin parenteral nutrition solution.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: the lot was manufactured from july 11, 2020 - july 13, 2020.H10: the device was received for evaluation.Unaided visual inspection was performed which observed solution and leaking in a sealed bag.A functional testing was performed which revealed a leak at the spike port bonding area.The reported condition was verified.The cause of the condition could not be determined; however the most likely cause is due to inadequate or lack of cyclohexanone applied to the spike port cap tube when it was inserted to the spike port during the manufacturing process causing an incorrect bonding.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: 1000 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11338985
• MDR Text Key: 232828990
• Report Number: 1416980-2021-00703
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: H938739
• Device Lot Number: 60249585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1