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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER BAXTER ONE-LINK IV TUBING CONNECTOR

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BAXTER BAXTER ONE-LINK IV TUBING CONNECTOR Back to Search Results
Lot Number (10)UR17FO7094
Device Problem Leak/Splash (1354)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 09/20/2017
Event Type  malfunction  
Event Description
Piv inserted and iv connector tubing placed on hub of needle and screwed on via luer lock. Flushed with normal saline and clamped. Blood back flowing and leaking out of connector tubing at hub distal to luer lock connector but before clamp. New connector placed without further signs of leaking from piv. Date of use: (b)(6) 2017. Diagnosis or reason for use: peripheral intravenous line. "is the product compounded: no; is the product over-the-counter: no; event abated after use stopped or dose reduced: yes. ".
 
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Brand NameBAXTER ONE-LINK
Type of DeviceIV TUBING CONNECTOR
Manufacturer (Section D)
BAXTER
deerfield IL 60015
MDR Report Key6885774
MDR Text Key87231235
Report NumberMW5072283
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 09/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number(10)UR17FO7094
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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