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 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a 2000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag leaked from the center port.This issue was identified during check after compounding.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: the lot was manufactured from october 22, 2019 - october 23, 2019.H10: the actual sample was received for evaluation.Unaided visual inspection was performed which 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 tube and the spike port bonding area.The reported condition was verified.The cause of the condition was 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: 2000 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10494095
• MDR Text Key: 205673372
• Report Number: 1416980-2020-05456
• 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: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: H938740
• Device Lot Number: 60211341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Date Manufacturer Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1