MAUDE Adverse Event Report: BAXTER HEALTHCARE ¿ ROUND LAKE 250 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938737

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 11/26/2018

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 250 ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag was leaking from the lower right corner on the seal of the bag.The leak was discovered prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was manufactured between 06/27/2018 - 06/28/2018.The actual device was received for evaluation.Visual inspection did not identify any issue with the seam of the bag in the lower right corner.However, visual inspection did observe a small tear in the lower left side edge of the bag.Functional testing was performed and a leak was observed from the tear in the lower left side of the bag only.Therefore, the reported issue of leak in the lower right corner was not verified, but a leak was verified in the lower left side of the bag.The cause of the condition could not be 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: 250 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE ¿ ROUND LAKE; round lake IL
• Manufacturer (Section G): BAXTER HEALTHCARE ¿ ROUND LAKE; 25212 w. illinois route 120; round lake IL
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8187616
• MDR Text Key: 131135006
• Report Number: 1416980-2018-07958
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477213
• UDI-Public: (01)00085412477213
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: H938737
• Device Lot Number: 60133469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 01/28/2019
• Supplement Dates FDA Received: 01/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1