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

Catalog Number 2B8071

Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 02/24/2020

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a vial-mate adapter experience coring incident while reconstituting vancomycin 1.5g/vial with a normal saline 500ml bag.This was identified after reconstitution, during setup and preparation.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added: the device was received for evaluation.Visual inspection was performed using the naked eye which observed that the device was not in the activated position and was not docked to a vial.Additional inspection observed a particulate matter in the attached drained solution bag.The particulate matter was identified to be a stopper material from the vial.The reported condition was verified.The cause of the condition was potentially due to the user misuse causing stopper material to dislodge into the fluid path.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: VIAL-MATE RECONSTITUTION DEVICE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• 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: 9862953
• MDR Text Key: 184422176
• Report Number: 1416980-2020-01612
• 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,health
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/20/2020

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
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 04/13/2020
• Supplement Dates FDA Received: 04/20/2020
• 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: Unknown
• Patient Sequence Number: 1