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

Catalog Number	ME2020
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One set model me2020, lot 25095265 was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was unable to be primed with water due to dried up medication in the line.Both luer locks were cut from the set and pressure tested while being attached to a bd extension set.No leak was observed.The customer complaint was unable to be replicated.The root cause could not be determined because the issue could not be replicated.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.
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.
Event or Problem Description
It was reported "medication was leaking from the medication line, between the luer lock and the line".No patient harm.

• 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: 24662046
• Report Number: 9616066-2026-00734
• Device Sequence Number: 21154584
• Product Code: FPA
• UDI-Device Identifier: 10885403236259
• UDI-Public: (01)10885403236259(17)300904(10)25095265
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: ME2020
• Device Lot Number: 25095265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown