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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION VIAL-MATE RECONSTITUTION DEVICE SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number 2B8071
Device Problem No Flow (2991)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The event occurred on an unspecified date in (b)(6) 2019. Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that seven (7) vial-mate reconstitution devices would not completely deliver vancomycin during administration. This was identified during patient use. There was no report of patient injury or medical intervention associated with this event. No additional information is available.

 
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Brand NameVIAL-MATE RECONSTITUTION DEVICE
Type of DeviceSET, 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 Key9292325
MDR Text Key166388716
Report Number1416980-2019-06178
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK142600
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/06/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/07/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device Catalogue Number2B8071
Device LOT NumberASKU
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2019
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

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