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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. SMARTSITE BURETTE INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION 303, INC. SMARTSITE BURETTE INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2447-0007
Device Problem Device Slipped (1584)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/16/2021
Event Type  malfunction  
Event Description
The blue stopper/rubber top of a gammagard s/d 50ml bottle fell into the medication bottle as bottle was being spiked with a buretrol tubing setup. Gammagard s/d bottle due to be spiked; primed, and then medication to be administered to patient. It has been noted, that with previous setups; that spiking could create a vacuum causing the buretrol to compress inwards. Therefore, prior to spiking this bottle; rn inserted a blunt needle with a syringe (no additional air injected into bottle). Syringe removed to decompress and let air out of bottle. Blunt needle removed. When spiking the bottle, the blue stopper/rubber top fell into glass bottle. Process was stopped and bottle put aside. Bd alaris burette set ref #: (b)(4), lot: (10)21076214; date: (17)2024-07-22. Med bottle brought to level 5 pharmacy and rn spoke with pharmacists. Pharmacists mentioned this is third time this has happened recently. R: bring to attention of medication manufacturer. Waiting for pharmacy to provide more information or education in the administration process with gammagard s/d bottles. Pharmacy is currently: investigating this product lot with the manufacturer. Assessing next steps and any changes in pharmacy compounding practice for any subsequent doses to help ensure that this event is not repeated. There was no harm in this event.
 
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Brand NameSMARTSITE BURETTE INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd
san diego CA 92121
MDR Report Key12696830
MDR Text Key278357667
Report Number12696830
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 10/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2447-0007
Device Catalogue Number2447-0007
Device Lot Number21076214
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/22/2021
Event Location No Information
Date Report to Manufacturer10/26/2021
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?
Type of Device Usage Unkown

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