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

Catalog Number	10016073
Medical Device Problem Code	Material Discolored (1170)
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
Post investigation findings identified, embedded foreign matter within the drip chamber.
Additional Manufacturer Narrative
The customer reported embedded black particulates in the drip chamber, and returned 3 unused samples of material 10016073, lot 25093219.Upon initial visual examination, the set confirmed the report of black particulate within the drip chamber.The supplier of the drip chamber component was notified of the failure.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 root cause for the issue was unable to be identified by the supplier.

• 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: 24791168
• Report Number: 9616066-2026-00894
• Device Sequence Number: 18573797
• Product Code: FPA
• UDI-Device Identifier: 10885403230110
• UDI-Public: (01)10885403230110(10)25093219
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• 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): 04/06/2026

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: 10016073
• Device Lot Number: 25093219
• 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: 04/03/2026
• Initial Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown