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 11/21/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported an exactamix 3000 ml eva tpn bag was leaking at the side seam.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The lot was manufacturing between july 20, 2018 and july 23, 2018.The device was received for evaluation.A visual inspection was performed at it was noted that there was a small tear in the lower right side of the front of the bag and near the edge.Functional testing was performed and a leak was identified from the small tear in the bag.The reported condition was verified.The cause of the reported condition was undetermined.This issue is being further investigated.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 ¿ ROUND LAKE; round lake IL
• Manufacturer (Section G): BAXTER HEALTHCARE ¿ ROUND LAKE; 25212 w. illinois route 120; round lake IL 22444
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8189014
• MDR Text Key: 131135263
• Report Number: 1416980-2018-07932
• 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: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: H938741
• Device Lot Number: 60138373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2019
• 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