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

Catalog Number 2B8071

Device Problems Cap (424); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 08/29/2019

Event Type  Malfunction  

Manufacturer Narrative

The device has been received and the evaluation is in progress. Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a piece of the vial stopper went into the vial with the fluid while using a vial-mate reconstitution device; further described as ¿coring¿. This was identified during set-up, while the nurse was mixing vancomycin prior to patient use. There was no patient involvement. No additional information is available.

Manufacturer Narrative

Additional information : the device was received for evaluation. A visual inspection was performed which observed a particulate matter in the attach vial and not on the device. The device was disassembled and an unknown substance was observed inside the silver cap of the vial. A functional testing was performed with no issues noted. The reported problem was verified. The cause of the condition could not be determined. 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: 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: 9112236
• MDR Text Key: 160183589
• Report Number: 1416980-2019-05232
• 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: 10/28/2019

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 09/24/2019
• 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: GR19D24024
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/17/2019
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 04/30/2019
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage