MAUDE Adverse Event Report: BAXTER HEALTHCARE - ENGLEWOOD 2000 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938740

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem No Patient Involvement (2645)

Event Date 03/14/2018

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 three (3) 2000ml exactamix eva tpn bags had leaked from a hole.This event occurred before use of the device.There was no patient involvement.No additional information is available.

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The samples were not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: 2000 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE - ENGLEWOOD; englewood CO
• Manufacturer (Section G): BAXTER HEALTHCARE - ENGLEWOOD; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7403542
• MDR Text Key: 104607481
• Report Number: 1416980-2018-01929
• Device Sequence Number: 1
• Product Code: LHI
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: H938740
• Device Lot Number: 60086988
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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