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

Catalog Number	30873
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by a customer that they had a hole in the tubing which allowing air to enter the tubing.When this nurse and (b)(6) were completing pts bath, it was found that there was a decent amount of air in the pca iv tubing post channel.The infusion was immediately stopped and upon further investigation it was found that the side infusion port had a hole that was allowing air to enter the tubing.Critical care team was notified and ecg was obtained.No other symptoms identified.
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.D.Several lot numbers were provided reflecting the lot numbers the facility has on hand.The lot number associated with this event is unknown.
Additional Manufacturer Narrative
Additional information: initial reporter's address.H10: the customer reported there was a hole in the tubing, and returned one used sample of material 30873, lot unknown but several were reported.Upon initial visual examination, the set had no defects or abnormalities.The set was tested at the different ports, and eventually the report was confirmed with a leak from a crack in the female luer on the back chack valve extension.The female luer was cracked and allowing for a leak, and component damage was verified.A device history record review was performed for the potential lots listed by the customer.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The female luer with crack was sent to the supplier of the component for further analysis.The supplier found no other similar issue on the lots listed, and the issue did not exceed acceptable quality limits.The issue was not identified as a manufacturing issue, and all monitoring and quality assurance practices passed for these manufactured lots.The root cause is unknown.The potential issue listed is the part coming into contact with a chemical which embrittled the part.
Event or Problem Description
No additional information was provided.

• Brand Name: ALARIS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• 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: 24406086
• Report Number: 9616066-2026-00469
• Device Sequence Number: 21308577
• Product Code: FPA
• UDI-Device Identifier: 10885403273940
• UDI-Public: (01)10885403273940(10)25115704
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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: 30873
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown