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

Model Number	30263E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event is unknown; awareness date has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd alaris smartsite extension set there was component separation.There was no report of patient impact.The following information was provided by the initial reporter: additional samples were received from the customer with the below defect.30263e - qty 1 lot 22059434- in sample 1 the issue of separation observed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 25-apr-2023.H6: investigation summary total 4 different samples were received with the related complaint from the customer.Evaluation of the extension set shows that two different material sets received as connected with each other and the functional testing was performed on gravity set tube which shows separation of tubing from the drip chamber.Further visual inspection under magnification shows a lack of solvent on the tubing.Because of separation, priming of set could not be possible.Quality notification send to manufacturer.A device history record review for model 30263e and lot number 22059434 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot.A trend for the drip chamber issue has been identified for this product line.The appropriate personnel have been notified of this complaint.We have funded a project to examine how to further increase the robustness of the disposable device and prevent future occurrences of this type.As part of the action plan, changes to the solvent dispenser are in the process of being implemented.
Event or Problem Description
It was reported while using bd alaris smartsite extension set there was component separation.There was no report of patient impact.The following information was provided by the initial reporter: additional samples were received from the customer with the below defect.30263e - qty 1 lot 22059434- in sample 1 the issue of separation observed.

• Brand Name: BD 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 ; 8448235433
• MDR Report Key: 16725684
• Report Number: 9616066-2023-00672
• Device Sequence Number: 17944391
• Product Code: FPA
• UDI-Device Identifier: 50885403235205
• UDI-Public: (01)50885403235205
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 05/02/2023

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: 05/27/2025
• Device Model Number: 30263E
• Device Catalogue Number: 30263E
• Device Lot Number: 22059434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2022
• 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