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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. ONE-LINK SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER INTERNATIONAL INC. ONE-LINK SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 7N8399
Device Problems Break (1069); Contamination (1120); Leak/Splash (1354); Device Slipped (1584); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/15/2017
Event Type  malfunction  
Event Description
Per audits/staff interview, challenges associated with baxter one link needleless connectors have been identified. Multiple medical surgical/critical care units have commented as follows: "must line up perfectly and apply pressure or it slips and entry gets contaminated-this happens about 50% of the time", "even if you know how to do it, it doesn't always go on right", "if it aligns right and gets screwed on properly there are no issues, but threading it on the first time is hard", "ivs leak around the insertion site a lot now-possibly due to pressure and stretching of skin-not infiltrated-just leaky", "if tightened right, they're ok, but can slip and contaminate hub", "syringes pop off often and hub gets contaminated", "icu rn has difficulty placing the connector correctly due to it being clear (see-through), "the curos caps do not attach easily(it takes a few attempts to attach them properly)", "iv tubing broke off inside of connector" and "difficulties when drawing blood". No patient or staff member has been harmed. Follow up actions to date include:.
 
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Brand NameONE-LINK
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER INTERNATIONAL INC.
25212 w. illinois route 120
round lake IL 60073
MDR Report Key6935045
MDR Text Key88809764
Report Number6935045
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 09/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/10/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7N8399
Device Catalogue Number7N8399
Device Lot Number(10)UR16K13045
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/25/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer09/25/2017
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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