MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. NOT APPLICABLE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MX4452
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd maxguard administration set was leaking.The following information was received by the initial reporter with the following verbatim.It was reported by customer that about the two events below.1.Patient's iv had come apart and found a pool of blood in the patient's bed.2.Iv had come apart with one open end in the floor and the other end dripping a large pool of blood on the floor.
Additional Manufacturer Narrative
The customer reported iv set came apart, and returned three unopened samples and a photo of material mx4452, lots 24119120, 25029239, and 25039296.Upon initial visual examination, the physical sets had no defects or abnormalities.The photo verified the complaint of leakage, and showed that the leakage occurred at the luer connection of the tubing and the inlet of the first stopcock.The three physical sets were all infused with water by gravity, and the connections tested.There was no issues found on the sets, and the luer connection at the stopcock was watertight.A device history record review was performed.There were no quality notifications issued for the failure mode, for either of the three reported lots, reported by the customer during the production build of this set.The root cause for the connection issues/leakage could not be determined without a replicated failure.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
No additional information was provided.

• Brand Name: NOT APPLICABLE
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• 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: 22494185
• Report Number: 9616066-2025-01965
• Device Sequence Number: 18171004
• Product Code: FPA
• UDI-Device Identifier: 10885403274688
• UDI-Public: (01)10885403274688
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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
• Report Date (Section B): 07/21/2025

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: Other
• Device Catalogue Number: MX4452
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 07/30/2025
• 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