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

Catalog Number 2B8071

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2014

Event Type  malfunction  

Event Description

It was reported that a vial-mate reconstitution device was involved in a leak incident.This occurred during reconstitution.The reporter stated that a non-baxter vial leaked when the vial-mate was attached to it.The leak was observed ¿both when it was closed and when it was open for reconstitution.¿ there was no report of patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The device was manufactured from september 5th, 2014 to september 9th, 2014) a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was 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: IVT DISPOSABLE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE - CLEVELAND; 911 highway 61 north po box 1; cleveland MS 38732
• Manufacturer (Section G): BAXTER HEALTHCARE - CLEVELAND; 911 highway 61 north; po box 1; cleveland MS 38732
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4358563
• MDR Text Key: 5173876
• Report Number: 1416980-2014-47268
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/19/2019
• Device Catalogue Number: 2B8071
• Device Lot Number: GR14H19023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2015
• 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: Unknown
• Patient Sequence Number: 1