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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION IV TUBING; SET, ADMINISTRATION, INTRAVASCULAR
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BAXTER HEALTHCARE CORPORATION IV TUBING; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Leak/Splash (1354); Pressure Problem (3012)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/21/2022
Event Type  malfunction  
Event Description
Rn disconnected iv line at conclusion of hic drug# (b)(4) chemotherapy infusion.Due to back pressure from iv line, investigational drug splashed from iv tubing into rn's eye upon disconnection.Rn flushed eye immediately and reported to occupational health immediately for evaluation.Per occupational health, needlestick panel with hiv source patient to be drawn on patient.Iv tubing sequestered and sent to pharmacy.Employee following up with occupational health per occupational health recommendations.Manufacturer response for iv tubing, iv tubing (per site reporter) ongoing issue with baxter tubing.
 
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Brand Name
IV TUBING
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
MDR Report Key15758831
MDR Text Key303306903
Report Number15758831
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 11/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/01/2022
Event Location Hospital
Date Report to Manufacturer11/09/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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