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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A DE C.V. ALARIS PUMP INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A DE C.V. ALARIS PUMP INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2420-0007
Device Problems Disconnection (1171); Failure to Infuse (2340); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/28/2019
Event Type  malfunction  
Event Description
Unit director received a note from one of the rns this morning describing issue with from over the weekend. The first was an instance where the portion of the iv tubing that goes inside the iv pump chamber bubbled which would not allow the infusion to run. The second was a situation where iv tubing came apart at the connection point where the flexible tubing that goes in the chamber attaches to the blue knob that seats into the iv pump channel. Fda safety report id# (b)(4).
 
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Brand NameALARIS PUMP INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A DE C.V.
MDR Report Key8671271
MDR Text Key147239878
Report NumberMW5087123
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 05/31/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2420-0007
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/04/2019 Patient Sequence Number: 1
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