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U.S. Department of Health and Human Services

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

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BD, SWITZERLAND SARL BD ALARIS PUMP INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2426-0500
Device Problems Connection Problem (2900); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Insufficient Information (4580)
Event Date 05/27/2021
Event Type  malfunction  
Event Description
New bd alaris pump infusion set and the tubing was not connected to the chamber below the spike. This break sterility / cleanliness of the product and it needed to be wasted. Infusion center will keep the tubing for a short time if it needs to be collected.
 
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Brand NameBD ALARIS PUMP INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BD, SWITZERLAND SARL
MDR Report Key12149721
MDR Text Key261227344
Report NumberMW5102450
Device Sequence Number1
Product Code FPA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 07/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2426-0500
Device Lot Number(10)20053476
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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