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

Catalog Number 2B8071

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that a vial-mate reconstitution device leaked during reconstitution.There was no 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 location of the leak was around the end of the vial, between the vial-mate and vial.The drug that was being reconstituted was a vial of 500 mg azithromycin and 0.9% sodium chloride.The reporter stated that the vial was not flipped over to make sure that the needle had fully penetrated its stopper, and the vial-mate adapter was extended and locked throughout the entire process.This did not occur during therapy; however, the solution mix reportedly came into contact with the operator's skin.There was no report of injury or medical intervention associated with this event.No additional information is available.The event occurred sometime between approximately (b)(6) 2014.Evaluation summary: the vial-mate was returned for evaluation docked to a solution bag.An undocked vial was also received.Visual inspection was performed with no issues noted.A simulated use test was then performed using the vial-mate, the returned vial, and the returned solution bag.The steps on the device's label copy were followed to mix the solution and empty the vial, and the vial-mate functioned properly with no issues encountered.The reported leak was unable to be replicated; however, the vial-mate adapter being extended during the process was reported and is a known cause of leakage.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: 4003732
• MDR Text Key: 4704972
• Report Number: 1416980-2014-26217
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2014

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 Catalogue Number: 2B8071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2014
• Initial Date FDA Received: 08/12/2014
• 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