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

Catalog Number	70001B-07T
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported leakage.Primary or secondary tubing with texium ends would start leaking from the connection point.Leaks would regardless of how tight the connection was secured.
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
No additional information.
Additional Manufacturer Narrative
Correction: f code updated.Device manufacture date updated: 09/05/2025.

• Brand Name: ALARIS
• 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 ; 8473935694
• MDR Report Key: 24379434
• Report Number: 9616066-2026-00398
• Device Sequence Number: 10622942
• Product Code: FPA
• UDI-Device Identifier: 10885403240997
• UDI-Public: (01)10885403240997(10)25095250
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 05/07/2026

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: 70001B-07T
• Device Lot Number: 25095250
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: Not provided; 05/07/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 02/18/2026; 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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