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

Catalog Number 2B8071

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer reported observing leakage while using the vial-mate adapter.This observation was made upon attempting to mix a baxter dextrose solution.The customer reported that the solution would flow ¿right out¿ of the adapter, and that the leakage was noted from the three holes at the top of the ¿gripper.¿ this event occurred before patient use.No additional information is available.

Manufacturer Narrative

(b)(4).The device was manufactured 1/16/2014-1/21/2014.The device was not returned; therefore, an evaluation could not be conducted.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, IV 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: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3830487
• MDR Text Key: 4401544
• Report Number: 1416980-2014-16810
• 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
• Report Date: 04/30/2014

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 Expiration Date: 12/19/2018
• Device Catalogue Number: 2B8071
• Device Lot Number: GR13L19043
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/30/2014
• Initial Date FDA Received: 05/23/2014
• 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