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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORTION SET EXTENSION CLEARLINK DEHP STRAIGHT L42 IN 6.2 ML INTRAVENOUS MALE LUER LOCK S SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORTION SET EXTENSION CLEARLINK DEHP STRAIGHT L42 IN 6.2 ML INTRAVENOUS MALE LUER LOCK S SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 96730
Device Problems Difficult to Remove (1528); Retraction Problem (1536); Defective Device (2588); Unintended Movement (3026)
Patient Problem Hematoma (1884)
Event Date 11/16/2021
Event Type  malfunction  
Event Description
During piv placement, rn pressed the retract button on the iv and it did not retract. The piv went sideways upon hitting the retract button and became stuck in the catheter. It took 3 hands to remove the needle from the catheter and resulted in the vein blowing. Positive for covid -19 with fever. Fda safety report id # (b)(4).
 
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Brand NameSET EXTENSION CLEARLINK DEHP STRAIGHT L42 IN 6.2 ML INTRAVENOUS MALE LUER LOCK S
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORTION
MDR Report Key12877733
MDR Text Key281328565
Report NumberMW5105575
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 Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number96730
Device Catalogue NumberITEM # 96730
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/24/2021 Patient Sequence Number: 1
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