MAUDE Adverse Event Report: CAREFUSION SMARTSITE VIALSHIELD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MV0520
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The medwatch report listed serious injury for type of reportable event and disability/permanent damage as the event outcome, however no information was provided by the customer that indicated that any injury to the pharmacist occurred.There was a small spill while the pharmacist was compounding the medication.No details were provided.Lot number 9234 was given on medwatch, however it did not populate our product grid, therefore it is not completely certain that it is correct.No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda, which states: "defective smart site vial shield- during the withdrawal of a drug from a vial using the cstd, the top snapped off (white top piece) consequently removing the blue internal piece as well.Small chemotherapy spill occurred during this mixing process fda safety report".
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda, which states: "defective smart site vial shield- during the withdrawal of a drug from a vial using the cstd, the top snapped off (white top piece) consequently removing the blue internal piece as well.Small chemotherapy spill occurred during this mixing process fda safety report".
Additional Manufacturer Narrative
Correction on initial report: b.1, b.2 ( disregard disability) & h.1.

• Brand Name: SMARTSITE VIALSHIELD
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9312861
• Report Number: 9616066-2019-03153
• Device Sequence Number: 13962215
• Product Code: LHI
• UDI-Device Identifier: 10885403228117
• UDI-Public: 10885403228117
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K132863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2022
• Device Model Number: MV0520
• Device Catalogue Number: MV0520
• Device Lot Number: 9234
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability