• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER VIAL MATE SET, I.V., FLUID TRANSFER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAXTER VIAL MATE SET, I.V., FLUID TRANSFER Back to Search Results
Lot Number Y231373
Device Problems Detachment Of Device Component (1104); Material Fragmentation (1261)
Patient Problem No Information (3190)
Event Date 06/21/2017
Event Type  Malfunction  
Event Description

Vancomycin 1 gram via ndc 63323-284-20, lot ahd702 exp: 12/2018, mfr: fresenius kabi used with vial mate system and a normal saline 250mg bag, mfr: baxter, lot #y231373, exp: 10/2018. When vial mate system was activated, the vial was cored and grey piece of rubber was floating in the bag. Note: we are contacting the mfr of the vial mate and they will most likely want the product sent to them.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVIAL MATE
Type of DeviceSET, I.V., FLUID TRANSFER
Manufacturer (Section D)
BAXTER
MDR Report Key6662969
MDR Text Key78375345
Report NumberMW5070583
Device Sequence Number2
Product Code LHI
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PHARMACIST
Type of Report Initial
Report Date 06/21/2017
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE Involved in the Event:
Date FDA Received06/21/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device EXPIRATION Date10/01/2018
Device LOT NumberY231373
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

-
-