MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. ALARIS SMARTSITE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	30204E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter also notified the fda on (b)(6) 2022.Medwatch report # (b)(4).No product or photo was returned by the customer.The customer complaint of leaking blood at the connection could not be verified due to the product not being returned for failure investigation.A device history record review for model 30204e lot number 21039703 was performed.The search showed that a total of 17,603 units in 1 lot number was built on 27mar2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this failure could not be identified without a failure investigation.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.
Event or Problem Description
It was reported while using alaris smartsite extension set leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: batch/lot #: 21039703.Mat# 30204e.Leaking blood at the connection of extension set to hub of needle.
Additional Manufacturer Narrative
The initial reporter also notified the fda on (b)(6) 2022.Medwatch report # (b)(4).No product or photo was returned by the customer.The customer complaint of leaking blood at the connection could not be verified due to the product not being returned for failure investigation.A device history record review for model 30204e lot number 21039703 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 27mar2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this failure could not be identified without a failure investigation.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.
Event or Problem Description
It was reported while using alaris smartsite extension set leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: batch/lot #: 21039703.Mat# 30204e.Leaking blood at the connection of extension set to hub of needle.

• Brand Name: ALARIS SMARTSITE EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13457343
• Report Number: 9616066-2022-00078
• Device Sequence Number: 6199657
• Product Code: FPA
• UDI-Device Identifier: 50885403235175
• UDI-Public: 50885403235175
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2022

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: Other
• Device Expiration Date: 03/26/2024
• Device Model Number: 30204E
• Device Catalogue Number: 30204E
• Device Lot Number: 21039703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown