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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK NITROGLYCERIN SET WITH DUO-VENT SPIKE SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION CLEARLINK NITROGLYCERIN SET WITH DUO-VENT SPIKE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2C8851
Device Problem Failure to Prime (1492)
Patient Problem No Patient Involvement (2645)
Event Date 12/01/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6). (b)(4). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a clearlink system nitroglycerin set would not prime. The priming failure occurred while attempting to prime with unspecified intravenous (iv) fluids prior to patient use. There was no patient involvement. No additional information is available.
 
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Brand NameCLEARLINK NITROGLYCERIN SET WITH DUO-VENT SPIKE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - CARTAGO
see h10
see h10
cartago 30106
CS 30106
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key11089413
MDR Text Key224757016
Report Number1416980-2020-08157
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00085412046365
UDI-Public(01)00085412046365
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K150860
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2C8851
Device Lot NumberR20D24107
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/25/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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