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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY PHASEAL PROTECTOR P14; SET, IV FLUID TRANSFER
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BECTON, DICKINSON AND COMPANY PHASEAL PROTECTOR P14; SET, IV FLUID TRANSFER Back to Search Results
Model Number P14
Device Problems Air Leak (1008); Leak/Splash (1354); Chemical Spillage (2894); Device Operates Differently Than Expected (2913)
Patient Problem Chemical Exposure (2570)
Event Date 04/27/2017
Event Type  malfunction  
Event Description
An iv room technician was drawing up 2.5 ml from a vial of cytarabine using the phaseal closed-system transfer device (vial was capped w/phaseal o14 protector using the phaseal assembly fixture).When the technician tapped the syringe to remove air bubbles, drips of chemo from the vial splattered around the hoods and the drug started streaming profusely down the technician's (gloved) hand.Technician seated leaking drug vial w/attached syringe in a bag and disposed of it.Chemo spill in hood warranted a deep cleaning of the hood with appropriate deactivating agents.Technician also had to change her chemo gown and sterile cover-alls, as a few drips of the drug flew under the sash of the hood and landed on her.This incident was a failure of the phaseal closed-system transfer device that resulted in far more chemo exposure to the technician and chemo contamination of the hood than would traditional mixing practices (sans-cstd).
 
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Brand Name
PHASEAL PROTECTOR P14
Type of Device
SET, IV FLUID TRANSFER
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
MDR Report Key6540495
MDR Text Key74409230
Report NumberMW5069506
Device Sequence Number1
Product Code FPA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/02/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received05/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberP14
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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