MAUDE Adverse Event Report: CAREFUSION SMARTSITE GRAVITY SET; SET, EXTENSION, INTRAVASCULAR

Model Number	42502E
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.No investigation was performed.
Event or Problem Description
The anesthesia team reported that the tubing is disconnecting where the 4 way stopcock port attaches to the rest of the set while connected to a patient and fluid is spilling out.There was no harm.

• Brand Name: SMARTSITE GRAVITY SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8460289
• Report Number: 9616066-2019-00874
• Device Sequence Number: 2926873
• Product Code: FPA
• UDI-Device Identifier: 10885403235382
• UDI-Public: 10885403235382
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2019

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: 42502E
• Device Catalogue Number: 42502E
• 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: 03/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Weight: 23