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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP. ONE-LINK SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORP. ONE-LINK SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 7N8301
Device Problems Sticking (1597); Connection Problem (2900); Device Operates Differently Than Expected (2913)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 05/15/2016
Event Type  malfunction  
Event Description
The charge nurse found the patient bleeding from iv access due to failed connection. The one-link needle free iv connector came unscrewed from the non-dehp standard bore catheter extension. The patient lost approx. 20-30 cc of blood. The needle free connector did not come loose from the iv line tubing and pump, allowing continued flow of infusion (heparin). The nurse changed the one-link needle free connector to resolve the problem. The nurse believes that the plastic wings on the catheter extension set are situated in such a way that it allows for an incident loosening of the luer lock connection, which is what was believed to have occurred.
 
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Brand NameONE-LINK
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORP.
25212 w. illinois route 120
round lake IL 60073
MDR Report Key5959609
MDR Text Key55052664
Report Number5959609
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
Type of Report Initial
Report Date 08/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2016
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7N8301
Device Lot Number07-36-71-494
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/19/2016
Event Location Hospital
Date Report to Manufacturer08/19/2016
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

Patient Treatment Data
Date Received: 09/19/2016 Patient Sequence Number: 1
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