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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY / CAREFUSION 303, INC. ALARIS PUMP INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

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BECTON DICKINSON AND COMPANY / CAREFUSION 303, INC. ALARIS PUMP INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2260-0500
Device Problems Break (1069); Particulates (1451)
Patient Problem Insufficient Information (4580)
Event Date 10/05/2021
Event Type  malfunction  
Event Description
Nurse report of plastic tip of iv set bag spike and tiny particles of plastic iv bag spike floating within the iv bag.Upon discovery, new medication and iv administration set were obtained.Plastic barrel of spike was sheared off at the base of the 4 openings near the tip of the spike.Fda safety report id # (b)(4).
 
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Brand Name
ALARIS PUMP INFUSION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BECTON DICKINSON AND COMPANY / CAREFUSION 303, INC.
MDR Report Key12648521
MDR Text Key277624561
Report NumberMW5104674
Device Sequence Number1
Product Code FPA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 10/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/14/2024
Device Model Number2260-0500
Device Catalogue Number2260-0500
Device Lot Number10-21056018
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/15/2021
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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