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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD CAREFUSION / CAREFUSION 303, INC. BD ALARIS PUMP INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

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BD CAREFUSION / CAREFUSION 303, INC. BD ALARIS PUMP INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number (10)20115880
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/20/2021
Event Type  Injury  
Event Description
Rn was reattaching iv tubing she noticed something floating in the iv tubing. Rn told patient that she was going to get her new fluids and new tubing since she just got out of the shower and then removed the affected tubing from the patient's room. After visual inspection, the ns 1l bag was not expired and there was a visible particle in the iv tubing. From where the particle is located, it does not appear that this particle came from the ns bag. It appears to be at a ysite location. The pt had metoclopramide, prochlorperazine, and diphenhydramine ivpush administered during this 24 hr timeframe. None of these medications would be expected to cause this result in the iv tubing unless there was contamination while attaching the medication to the iv tubing. We would never be able to confirm or deny that. The most likely cause is that this particle was already present in the iv tubing before being removed from the package and used on the pt. The iv tubing used is bd alaris pump infusion set. Primary set ref (b)(4) and secondary set ref (b)(4). Fda safety report id# (b)(4).
 
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Brand NameBD ALARIS PUMP INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BD CAREFUSION / CAREFUSION 303, INC.
MDR Report Key12275481
MDR Text Key265163605
Report NumberMW5102959
Device Sequence Number1
Product Code FPA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 07/30/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number(10)20115880
Was Device Available for Evaluation? No
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: 08/03/2021 Patient Sequence Number: 1
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