MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) AND STOPCOCK; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MX4452
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxguard administration set with needleless y-site(s) and stopcock had disconnection.The following information was provided by the initial reporter: (b)(6) 2025 - iv tubing came disconnected twice during surgery.Additional information received from the customer: is the lot number known? no.Were there any adverse events associated with this incident? patient safety and increased risk of infection.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Three photos were provided by the customer for quality evaluation.None of the photos provided show an issue of the tubing set disconnection or a disconnection with any other external set connected to the maxzero connector.The customer complaint of disconnection could not be verified.A root cause could not be determined because the failure was not depicted in the photo provided, a physical sample was not provided for testing, and the lot number was reported as unknown.A device history record review could not be performed because the lot number is unknown.

• Brand Name: BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) AND STOPCOCK
• 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: 22401347
• Report Number: 9616066-2025-01823
• Device Sequence Number: 12835683
• 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: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 10/01/2025
• 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