MAUDE Adverse Event Report: BAXTER HEALTHCARE - CLEVELAND VIAL-MATE RECONSTITUTION DEVICE; SET, I.V. FLUID TRANSFER

Catalog Number 2B8071

Device Problems Fluid/Blood Leak (1250); Connection Problem (2900)

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

Event Date 08/22/2017

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation attached to a solution bag and a product vial.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed on the device, and the solution flow was observed as expected.The reported condition was not verified.The device was found to operate per specification.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a leak was observed between a vial-mate reconstitution device and a vial.The reporter indicated that this occurred before activation, and clarified that the vial involved in the event had been previously detached from another vial-mate adapter, and reattached to the vial-mate adapter alleged to have leaked.The solution being used was a 100ml baxter solution bag of 0.9% saline solution.The customer indicated that solution leaked onto the customer's and pharmacist's skin; however, there was no patient reaction or medical intervention reported.No additional information is available.

• Brand Name: VIAL-MATE RECONSTITUTION DEVICE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE - CLEVELAND; cleveland MS
• Manufacturer (Section G): BAXTER HEALTHCARE - CLEVELAND; 911 highway 61 north; po box 1058; cleveland MS 38732
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6870214
• MDR Text Key: 86455383
• Report Number: 1416980-2017-07563
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2B8071
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Date Manufacturer Received: 08/22/2017
• 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