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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER INTERNATIONAL, INC. BAXTER NON-DEHP STANDARD BORE CATHETER EXTENSION SET-POWER SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER INTERNATIONAL, INC. BAXTER NON-DEHP STANDARD BORE CATHETER EXTENSION SET-POWER SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2N1333
Device Problems Fluid Leak (1250); Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/24/2019
Event Type  malfunction  
Event Description
Noticed iv was leaking during free maintenance drip after iv start in pre-post. Extension set failure: male luer lock adapter was loose at the point of where it is normally bonded to the rest of the extension piece. Extension was changed and upon inspection the male luer lock was easily displaced from the rest of the extension set.
 
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Brand NameBAXTER NON-DEHP STANDARD BORE CATHETER EXTENSION SET-POWER
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER INTERNATIONAL, INC.
25212 w. illinois route 120
round lake IL 60073
MDR Report Key8669723
MDR Text Key147031704
Report Number8669723
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/29/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2N1333
Device Catalogue Number2N1333
Device Lot Number10 UR 19A26010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/29/2019
Event Location Hospital
Date Report to Manufacturer06/05/2019
Was Device Evaluated by Manufacturer? No Answer Provided
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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