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	06/03/2025
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 the bd maxguard administration set with needleless y-site(s) and stopcock had disconnection issues.The following information was provided by the initial reporter: 6/3/25 - iv disconnecting issues.Additional information received from the customer: impacted lot number: unknown.Were there any adverse events associated with this incident? potential patient safety and infection risk.
Additional Manufacturer Narrative
The customer reported multiple complaints.One sample and one photo were received for quality evaluation.The sample submitted was visually examined and there were no damages or abnormalities to the sample.The sample was primed with water and observed for any component damage - leak.There were no indications of component damage through the sample submitted.The photo received shows two stopcock connections that are disconnected, with blood within the fluid paths, however, the photo does not depict any of the components in the photo being damaged.The customer complaint of component damage - leak could not be confirmed.A root cause for the reported issue was not determined because the failure reported could not be duplicated.A device history record review could not be performed because the lot number is unknown.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information was provided.

• 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: 22342264
• Report Number: 9616066-2025-01728
• Device Sequence Number: 4901460
• 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): 09/24/2025

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: 06/03/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 09/30/2025
• 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