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 Date 09/09/2020

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 three (3) units of 2000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags had external fluid leakage form the port.This issue was identified during setup and 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: the lot was manufactured from january 28, 2020 - january 29, 2020.H10: three (3) actual samples were received for evaluation.Unaided visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed which revealed a leak between the spike port cap tube and the spike port bind area in all samples.The reported condition was verified.The cause of the condition was not determined; however, the most likely cause was due to inadequate or lack of cyclohexanone applied to the spike port cap tube when it was inserted to the spike port causing an incorrect bonding 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: 10623730
• MDR Text Key: 209771796
• Report Number: 1416980-2020-06169
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: H938740
• Device Lot Number: 60225035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1