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

Catalog Number H938741

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2020

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 four (4) 3000 ml eva (ethylene vinyl acetate) tpn (total parenteral nutrition) bags leaked.It was further reported that three (3) of the bags burst during compounding and one (1) of the bags burst in the box.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: the device was manufactured from september 19, 2019 ¿ september 21, 2019.H10: six (6) samples were received for evaluation.Unaided visual inspection was performed which observed a large tear across the top seam in front of the bag in sample one and two.Additional magnified inspection was performed which verified a small tear at the top seam in front near the hanger hole on the third sample.Functional testing was performed which revealed a leak at the top seam on the three samples.The reported condition was verified only in the three (3) samples.The cause of the reported condition was not verified.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: 3000 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9662139
• MDR Text Key: 178119216
• Report Number: 1416980-2020-00369
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477251
• UDI-Public: (01)00085412477251
• Combination Product (y/n): N
• 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
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: H938741
• Device Lot Number: 60205999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Initial Date Manufacturer Received: 01/08/2020
• Initial Date FDA Received: 02/03/2020
• Supplement Dates Manufacturer Received: 02/18/2020
• Supplement Dates FDA Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1