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

Model Number	11088483
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.Although requested, patient demographic details were not provided.The patient is a child.
Event or Problem Description
It was reported that tubing disconnected and leaked at the needleless connector during a fentanyl infusion.There was no patient harm as a result of the event.
Additional Manufacturer Narrative
The customer¿s report that the tubing disconnected and leaked at the needleless connector was not confirmed.Functional testing of priming and infusion testing did not replicate any leaks or disconnections at the connection between the smartsite and extension set or anywhere else throughout the set.The received extension set and smartsite connector¿s female and male luer ports were measured and found to be within iso standards.The root cause of the customer¿s report could not be determined.
Event or Problem Description
It was reported that tubing disconnected and leaked at the needleless connector during a fentanyl infusion.There was no patient harm as a result of the event.

• Brand Name: ALARIS® EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8540551
• Report Number: 9616066-2019-01096
• Device Sequence Number: 361109
• Product Code: FPA
• UDI-Device Identifier: 10885403234668
• UDI-Public: 10885403234668
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2019

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: 11088483
• Device Catalogue Number: 11088483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2000E, SYRINGE; 2000E, SYRINGE