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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.
 
Manufacturer Narrative
H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed including pressure testing and clear passage testing and no issues noted.Prime testing was also performed, and the set performed to specification with no issue noted.The reported condition was not verified.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 Name
CLEARLINK NITROGLYCERIN SET WITH DUO-VENT SPIKE
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
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
PMA/PMN Number
K150860
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/27/2021
1 Device was Involved in the Event
1 Patient was 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
Date Manufacturer Received01/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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