MAUDE Adverse Event Report: BAXTER HEALTHCARE ¿ ROUND LAKE 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 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that two (2) exactamix eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags, 3000ml, were leaking on the side corner end of the bags on the seams and on the middle ports.The issues were identified during unspecified process steps.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Two actual samples were received sliced at the top where the customer likely drained the contents.Visual inspections were performed with the unaided eye.Functional tests were performed which revealed a leak from the spike port weld of one sample.Magnified inspection observed a tear/hole at the spike port weld.Functional tesing of the other sample revealed a leak from the lower left corner in front of the bag just above the seam (were the customer had marked the alleged area of the leak).Magnified inspection observed a tear/hole at the lower left corner in front of the bag just above the seam where the leak occurred.The reported conditions were verified.The cause of the conditions could not be determined.Batch reviews were conducted and there were no deviations found related to this reported conditions during the manufacture of this lot.This issue is being further investigated.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 ¿ ROUND LAKE; round lake IL
• Manufacturer (Section G): BAXTER HEALTHCARE ¿ ROUND LAKE; 25212 w. illinois route 120; round lake IL 60073
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8203383
• MDR Text Key: 131643069
• Report Number: 1416980-2018-08060
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477251
• UDI-Public: (01)00085412477251
• 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: 02/01/2019

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: 06/30/2020
• Device Catalogue Number: H938741
• Device Lot Number: 60073296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 01/28/2019
• Supplement Dates FDA Received: 02/01/2019
• 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