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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - CLEVELAND VIAL-MATE RECONSTITUTION DEVICE SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number 2B8071
Device Problem No Flow (2991)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

The reported event occurred sometime in 2016. The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that a vial-mate adapter took 15 minutes to get normal saline into and out of the vial. 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 - 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 Key6130446
MDR Text Key60990123
Report Number1416980-2016-17710
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,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 11/28/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/28/2016
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/04/2016
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

Patient TREATMENT DATA
Date Received: 11/28/2016 Patient Sequence Number: 1
Treatment
SALINE
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