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

Catalog Number	MX5301
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that we had 4 of these extension sets with blockage, unable to flush.No patient harm.
Additional Manufacturer Narrative
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
No further information was provided.
Additional Manufacturer Narrative
It was reported by customer that we had 4 of these extension sets with blockage, unable to flush.One sample was received for quality evaluation.Visual inspection was conducted and no damages or abnormalities were identified.The sample was attempted to be primed but there was an occlusion in the fluid path no allowing for flow.Further examination of the sample under magnification indicates that there is a blockage at the inlet port of the smartsite.The customer complaint of flow issues - fluid blockage was confirmed.An occlusion between these components could be related to an excess of solvent in the engagement due to issues with the solvent dispenser or due to an incorrect follow up of the work instructions by the assembler (incorrect use of solvent dispenser or omission of flow test).An investigation at the manufacturing facility was conducted regarding the issue.Improvements to the manufacturing process have been implemented through an engineering corrective action released on january 20th, 2026, after the manufacturing of lot 25095496 (lot mfg.Date september 24th, 2025), to update the standard work instruction to assign the responsibility to the solvent operators to verify the correct functioning of solvent dispensers after bushing changes and cleaning guide for bushings before placing it into the production line.A device history record review for model mx5301 lot number 25095496 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: MAXGUARD
• 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.; 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: 24462492
• Report Number: 9616066-2026-00526
• Device Sequence Number: 21176246
• Product Code: FPA
• UDI-Device Identifier: 10885403237553
• UDI-Public: (01)10885403237553(17)280912(10)25095496
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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: MX5301
• Device Lot Number: 25095496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown