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

Catalog Number	MX5301
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that the end that attaches to the iv primary line came apart from the tubing.
Additional Manufacturer Narrative
B3.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.E1.Address information was not provided; therefore, il was used as the state.Device evaluation: no product or photo was returned by the customer.The customer complaint of separation other component - leak could not be verified due to the product not being returned for failure investigation.A device history record review for material#: mx5301 and lot: 25085566 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 18aug2025.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

• 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: 24802763
• Report Number: 9616066-2026-00910
• Device Sequence Number: 15858172
• Product Code: FPA
• UDI-Device Identifier: 10885403237553
• UDI-Public: (01)10885403237553(17)280817(10)25085566
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 03/28/2026

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: 25085566
• 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: 03/24/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown