MAUDE Adverse Event Report: CAREFUSION SMARTSITE 4-WAY STOPCOCK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	10237425
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product returned.Because no product was returned or expected to be returned, no failure investigation could be performed.The root cause of the customer's experience was not identified.
Event or Problem Description
It was reported that upon opening the package for a stopcock a defect was noticed.The plastic threading on one end had a hole in it.The stopcock was not used.There was no patient involvement in this event.

• Brand Name: SMARTSITE 4-WAY STOPCOCK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9851163
• Report Number: 9616066-2020-01013
• Device Sequence Number: 14106317
• Product Code: FPA
• UDI-Device Identifier: 10885403234163
• UDI-Public: 10885403234163
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10237425
• Device Catalogue Number: 10237425
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1