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

Model Number	20051E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2019
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.
Event or Problem Description
The reported feedback suggests that blood was coming out from the deformed oval connector end.
Additional Manufacturer Narrative
The customer¿s report that blood was coming out from the deformed oval connector end was confirmed.Visual inspection identified the smartsite component to be oval in shape.Functional testing confirmed the customer¿s experience as leakage was identified from the oval-shaped smartsite.The root cause of this issue is exposure of the smartsite® to an external heat source that brings the component temperature above 60°c.The cause for this level of excess heat was not identified.
Event or Problem Description
The reported feedback suggests that blood was coming out from the deformed oval connector end.

• 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: 9403233
• Report Number: 9616066-2019-03486
• Device Sequence Number: 2626394
• 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,Followup
• Report Date (Section B): 11/11/2019

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 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: 11/19/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1