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

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.

• Brand Name: SMARTSITE BURETTE INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 12696830
• MDR Text Key: 278357667
• Report Number: 12696830
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2447-0007
• Device Catalogue Number: 2447-0007
• Device Lot Number: 21076214
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/22/2021
• Date Report to Manufacturer: 10/26/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 4380 DA