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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 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.

 
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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 Key9112236
MDR Text Key160183589
Report Number1416980-2019-05232
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 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 Received09/24/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number2B8071
Device LOT NumberGR19D24024
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/11/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/30/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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