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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SET WITH ONE-LINK NEEDLE-FREE IV CO SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SET WITH ONE-LINK NEEDLE-FREE IV CO SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 7N8399
Device Problems Difficult to Flush (1251); Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2015
Event Type  malfunction  
Event Description
One-link was attached to infant's new central line. Rn unable to flush through the line that was less than 24 hrs old. One-link had been replaced more than once over the night. It seemed to be sticking and nothing able to go through it.
 
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Brand NameNEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SET WITH ONE-LINK NEEDLE-FREE IV CO
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
25212 w. illinois drive route 120
round lake IL 60073
MDR Report Key5392779
MDR Text Key36914798
Report Number5392779
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Patient
Type of Report Initial
Report Date 12/31/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number7N8399
Device Lot Number07-36-71-510
Other Device ID NumberPEOPLESOFT 15259
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/31/2015
Event Location Hospital
Date Report to Manufacturer12/31/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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