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

Catalog Number	37262E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris smartsite extension set was leaking the following information was received by the initial reporter with the following it was reported by customer that they had a few extension sets #37262e leak out through the tubing.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
The customer reported the tubing was leaking and returned one used sample, and one unopened sample of material 37262e, lot 25085315.Upon initial visual examination, the sets had no defects or abnormalities.The used set was infused with water, and the complaint of leakage was verified at the tubing inlet of the 1st smart site.There was a straight line spray out of the connection from the top, on the smart site luer side.The tubing and smart site were pulled apart to examine the internal connection.Note: it was quite easy and took little force to separate.The unopened set was tested in the same manner, but no issues or defects were observed.A device history record review was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The manufacturing plant found the root cause for the separation to be related to incorrect solvent application by the assembler.The plant addressed the failure by upgrading the bushing cleaning guide in the solvent dispenser and adding more stabilization to the dispenser.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23977188
• Report Number: 9616066-2025-04083
• Device Sequence Number: 10626544
• Product Code: FPA
• UDI-Device Identifier: 10885403235276
• UDI-Public: (01)10885403235276(11)250808(17)280807(10)25085315
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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: Other
• Device Catalogue Number: 37262E
• Device Lot Number: 25085315
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown