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

Catalog Number 2B8071

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 08/08/2014

Event Type  malfunction  

Event Description

It was reported that a vial-mate reconstitution device leaked from ¿around the blue piece of the adapter¿, at the interface with a viaflex container (baxter product).This occurred as a nurse was performing reconstitution with 3.375 g of a non-baxter drug and before patient connection.This occurred immediately after admixture.The reporter stated that the vial-mate was securely attached to both the bag and vial.The needle was visibly penetrating the stopper and the vial-mate was fully activated.No irregularities were noticed with the vial-mate or its packaging.There was no patient involvement.No additional information is available.This is report 1 of 2.

Manufacturer Narrative

(b)(4).The device has been received and the evaluation is in progress.Upon completion of the device evaluation, or if any additional relevant information is received, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The lot was manufactured from may 9th, 2014 to may 13th, 2014.Evaluation summary: the device was returned for evaluation connected to an empty solution bag and a vial.Visual inspection was performed with no issues noted with the vial-mate, but it was docked to the incorrect port on the solution bag.A simulated use test was then performed using the vial-mate, the returned vial, and a new solution bag (connected at the correct port); the directions on the device's label copy were followed, and no issues were identified.The reported condition was unable to be replicated; however, connection of the vial-mate to an incorrect port on the bag was discovered and is a known cause of leakage.A review of all batch record documents was performed with no issues noted during the manufacturing process.There were no deviations from standard procedure and no exceptions related to the reported condition were noted.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: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 4053015
• MDR Text Key: 4859515
• Report Number: 1416980-2014-29300
• 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: Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 08/08/2014

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: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 2B8071
• Device Lot Number: GR14D30029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2014
• Initial Date FDA Received: 09/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/06/2014
• 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