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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON ALARIS SET, ADMINISTRATION, INTRAVASCULAR

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BECTON DICKINSON ALARIS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/26/2019
Event Type  malfunction  
Event Description
The blue valve of primary iv tubing at port closest to patient was found missing from set upon opening package. Issue was reported to the manufacturer and the infusion pump set will be returned. There was no harm to the patient. Lot number not available and submitted for tracking purposes.
 
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Brand NameALARIS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BECTON DICKINSON
one becton drive
franklin lakes NJ 07417
MDR Report Key9309322
MDR Text Key165989367
Report Number9309322
Device Sequence Number1
Product Code FPA
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 11/05/2019,09/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/05/2019
Event Location No Information
Date Report to Manufacturer11/12/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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