MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 3000 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938741

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

Uf/importer report number: mw5095602.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the middle port of two (2) units of 3000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags leaked.This was identified before patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: the lot was manufactured from november 21, 2019 - november 26, 2019.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: one (1) actual sample was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional testing was performed which revealed a leak between the spike port tube and the spike port bonding area.The reported condition was verified for the one sample.The cause of the condition was not determined; however, the most likely cause was due to inadequate or lack of cyclohexanone being applied to the spike port cap when it was inserted to the spike port tubing during the manufacturing process.The remaining sample was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: 3000 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10491042
• MDR Text Key: 205895201
• Report Number: 1416980-2020-05440
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477251
• UDI-Public: (01)00085412477251
• 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,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: H938741
• Device Lot Number: 60216300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1