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

Model Number	20051E
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer¿s report that the smartsites are deformed was confirmed.Visual inspection confirmed the customer's experience of an oval-shaped smartsite component.Functional testing was performed; leakage was observed from the oval-shaped smartsite.The cause of this issue is exposure of the smartsite® to an external heat source that brings the component temperature above 60°c.A review of the manufacturing process, bd storage conditions, and sterilization process has not found a potential root cause for this level of excess heat.
Event or Problem Description
The reported feedback suggests that the smartsites are deformed.Report suggests not in use on a patient.

• 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: 9497009
• Report Number: 9616066-2019-03701
• Device Sequence Number: 2967082
• Product Code: FPA
• UDI-Device Identifier: 07613203012331
• UDI-Public: 07613203012331
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2019

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 Expiration Date: 05/03/2022
• Device Model Number: 20051E
• Device Catalogue Number: 20051E
• Device Lot Number: 19055319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1