MAUDE Adverse Event Report: BAXTER HEALTHCARE ¿ ROUND LAKE 500 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938738

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a 500 ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag leaked from an unspecified location.This was observed prior to patient use.There was no patient involvement. no additional information is available.

Manufacturer Narrative

The device was received for evaluation.A note was also returned with the sample which indicated that the leak was observed by the customer at the middle port leak.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed and a leak was observed at the spike port cap.The reported condition was verified.The cause of the reported condition was undetermined.This issue is being further investigated.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: 500 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: 8197601
• MDR Text Key: 131438222
• Report Number: 1416980-2018-08010
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/28/2019

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 Catalogue Number: H938738
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 03/28/2019
• 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