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

Catalog Number	20039E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, extension set, kinked tubing during use.The following was provided by the initial reporter: during use of the 20039e extension set, an abnormal tubing kink was observed at the exit point of the securement wing.The tubing was sharply bent at the junction between the securement wing and the extension tubing, resulting in deformation of the lumen and potential restriction of fluid flow.The device was replaced upon discovery.There was one occurrence of this issue.Additional information: the lot number is unknown and unavailable.The anesthesiology department identified the issue during use when kinking of the tubing was observed.The fault was identified during infusion when a blockage was observed.The elapsed time before the issue occurred is unknown.The substance being infused at the time of the event is unknown.Unable to confirm whether any damage was observed to the individual set packaging, as the packaging is no longer available.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

• 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: 50839597
• Report Number: 9616066-2026-02379
• Device Sequence Number: 18711661
• Product Code: FPA
• UDI-Device Identifier: 07613203011952
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K061285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: 20039E
• 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: 09/11/2026
• Initial Report FDA Received Date: 09/21/2026
• 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