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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD PHASEAL; SET, I.V. FLUID TRANSFER
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BD PHASEAL; SET, I.V. FLUID TRANSFER Back to Search Results
Device Problems Disconnection (1171); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/11/2020
Event Type  malfunction  
Event Description
Patient called nurse for help, and rn went into the pt's room and found the iv tubing with tacrolimus was disconnected from the main runner line.Blood was found on the tubing, on the sheets, and on pt's legs.Upon investigation of the incident, it was found that the disconnect happened between the connector and the lowest port of tacro runner.The rn did not touch it/disconnect it during her shift.Blood back-flowed from the pt's cvc line to the runner tubing.Clam-shell was in use in this case with connector and injector in place.Manufacturer response for iv tubing connector, phaseal connector (per site reporter).Optima reps from within (b)(6) will be making arrangements to come on-site to round, observe, and discuss with staff.
 
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Brand Name
PHASEAL
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BD
5859 farinon dr ste 200
san antonio TX 78249
MDR Report Key10162130
MDR Text Key195383116
Report Number10162130
Device Sequence Number1
Product Code LHI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/18/2020
Event Location Hospital
Date Report to Manufacturer06/17/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age22265 DA
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