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

Model Number	10012213
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Because no product was returned or expected to be returned, no failure investigation could be performed.The root cause of the customer's experience was not identified.
Event or Problem Description
Received a copy of the customer's sus voluntary event report from fda which states, ¿care fusion extension set ref # (b)(4) leaking blood at point behind pt connection when primed to the end affected lots 19035714, 17116703, 17125852, 19025343".There was no customer/hospital name, address, or contact provided; no further information will be available.

• Brand Name: ALARIS EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8850030
• Report Number: 9616066-2019-02114
• Device Sequence Number: 19208439
• Product Code: FPA
• UDI-Device Identifier: 10885403233685
• UDI-Public: 10885403233685
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,use
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2022
• Device Model Number: 10012213
• Device Catalogue Number: 10012213
• Device Lot Number: 19035714
• 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: 08/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other