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 08/31/2020

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 a 1000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag was leaking from the injection tube.The leak was discovered prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: the lot was manufactured from november 27, 2019 - november 28, 2019.H10: the device was received for evaluation.Unaided visual inspection was performed which observed a tear at the lower right side edge of the bag.A functional test was performed which observed a leak in the tear location.Additional magnified inspection was performed which verified a small tear/hole at the lower right side edge which caused a leak.The reported condition of leak was verified; however, it was not located in the injection tube.The cause of the condition was not determined.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: 10567408
• MDR Text Key: 207942170
• Report Number: 1416980-2020-05888
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477237
• UDI-Public: (01)00085412477237
• 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: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• 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: H938739
• Device Lot Number: 60216314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1