MAUDE Adverse Event Report: CAREFUSION ALARIS GRAVITY SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	11059728
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	09/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
Event or Problem Description
It was reported that prior to the patient being induced, the nurse noticed that fluid was leaking from the tubing.The tubing was fractured.There was no patient harm.
Additional Manufacturer Narrative
The customer report of leaking and fractured tubing was not confirmed based on visual inspection, and functional and pressure testing of the as-received partial set sample.The as-received sample was inspected for kinks, holes/tears in the tubing or damages to the components.No obvious damages or issues were observed.All mated luer components were disconnected.No issues were observed with any of the recently mated components.The expected stopcock was not returned for investigation and could not be evaluated.The root cause of leaking and fractured tubing was unable to be identified.
Event or Problem Description
It was reported that prior to the patient being induced, the rn noticed that fluid was leaking from the tubing.The tubing was fractured.It was further confirmed during follow up, that there was no patient harm as a result of this event.

• Brand Name: ALARIS GRAVITY SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9178775
• Report Number: 9616066-2019-02783
• Device Sequence Number: 2568696
• Product Code: FPA
• UDI-Device Identifier: 10885403234644
• UDI-Public: 10885403234644
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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: 11059728
• Device Catalogue Number: 11059728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1