MAUDE Adverse Event Report: BAXTER HEALTHCARE - MALTA IVT DISPOSABLE; SET, I.V. FLUID TRANSFER

Catalog Number EMC7406T

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that a vialmate leaked.This occurred during reconstitution.There was no patient involvement.No additional information is available.This is report 2 of 7.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was received for evaluation attached to a viaflo bag.Visual inspection was performed and showed no defects related to the reported problem.The bag was hung up on a stand for at least 48 hours and no leakage was observed.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: IVT DISPOSABLE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE - MALTA; a47 industrial estate; malta b; marsa ; MT
• Manufacturer (Section G): BAXTER HEALTHCARE - MALTA; a47 industrial estate; malta b; marsa ; MT
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 4274509
• MDR Text Key: 5226408
• Report Number: 1416980-2014-42308
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2015
• Device Catalogue Number: EMC7406T
• Device Lot Number: 13C23V838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2014
• Date Manufacturer Received: 10/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1