MAUDE Adverse Event Report: Sistemas Medicos Alaris S.A de C.V. Alaris Smartsite; Set, Administration, Intravascular

Catalog Number	2000E CHINA
Medical Device Problem Codes	Leak/Splash (1354); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation result: a 2000e china product was not available for investigation; the lot number provided by the customer was incorrect.The feedback provided by the customer states that, "after the nurse inserted the iv cannula, she connected the iv connector and the infusion set but noticed that the connector was not securely attached".No further information was available to assist the investigation in this instance.The details of this feedback were forwarded to the manufacturing site for investigation.The lot number provided by the customer was incorrect and therefore it is not possible to perform a review of the production documentation for this particular product.The root cause of the customer¿s experience could not be determined in this instance as no sample was received for investigation.Without a sample to examine it is not possible to determine whether a manufacturing defect could have caused or contributed to a report of this nature.In this instance, without the complaint sample to examine it has not been possible to conclusively link this feedback to a specific failure mode; however, a review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the product 2000e china in the past 12 months.

• Brand Name: Alaris Smartsite
• Common Device Name: Set, Administration, Intravascular
• Manufacturer (Section D): Sistemas Medicos Alaris S.A de C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): Sistemas Medicos Alaris S.A de C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; +1(847)393-5694
• MDR Report Key: 50612418
• Report Number: 9616066-2026-02226
• Device Sequence Number: 10626205
• Product Code: FPA
• UDI-Device Identifier: 07613203011938
• UDI-Public: (01)07613203011938
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2026

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 Catalogue Number: 2000E CHINA
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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