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

Model Number MV0520

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 09/18/2019

Event Type  malfunction  

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 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 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".

Manufacturer Narrative

Correction on initial report: b.1, b.2 ( disregard disability) & h.1.

• Brand Name: SMARTSITE VIALSHIELD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9312861
• MDR Text Key: 166211927
• Report Number: 9616066-2019-03153
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 10885403228117
• UDI-Public: 10885403228117
• Combination Product (y/n): N
• PMA/PMN Number: K132863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability