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

Catalog Number 2B8071

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2021

Event Type  malfunction  

Manufacturer Narrative

The devices were received and are currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during preparation of intravenous medications, three (3) vial-mate adapters had a vial stopper coring issue.There was no patient involvement.No additional information is available.

Manufacturer Narrative

B5: there were four (4) affected products, previously submitted as three (3).H4: the lot was manufactured from january 22, 2021 to january 27, 2021.H10: three (3) devices were received for evaluation; along photographs of the event.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed in all samples and the device performed according to product specifications.No particulate matter was observed.The reported condition was not verified in the actual samples.Visual inspection was performed on the photographs using the naked which observed a gray particle in the vial in all provided photos.The reported condition was verified on the photographs.The cause of the condition could not be determined; however, based on the color and characteristics in the picture, the most probable identity of the particulate is stopper material.The fourth (4) device was not received; therefore, a device analysis could not be completed.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 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 ; 2242702068
• MDR Report Key: 12579858
• MDR Text Key: 274978222
• Report Number: 1416980-2021-06094
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412027388
• UDI-Public: (01)00085412027388
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K142600
• 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: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2B8071
• Device Lot Number: GR21A20017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2021
• 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: Initial
• Patient Sequence Number: 1