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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD ALARIS PUMP INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

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BD ALARIS PUMP INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2420-0007
Device Problems Fluid Leak (1250); Material Split, Cut or Torn (4008)
Patient Problem Insufficient Information (4580)
Event Date 09/05/2021
Event Type  malfunction  
Event Description
During the infusion, fluids began leaking and, after examination, a small slit was noted in the tubing about 1 1/2 inches below the last port. Fda safety report id# (b)(4).
 
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Brand NameALARIS PUMP INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BD
MDR Report Key12452811
MDR Text Key271068305
Report NumberMW5103830
Device Sequence Number1
Product Code FPA
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 09/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2420-0007
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

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