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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
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 leakage.The following information was provided by the initial reporter: (b)(6) 2025 - found iv tubing leaking during the surgery.Additional information received from the customer: is the lot number known? no were there any adverse events associated with this incident? potential patient safety and increased risk of infection.
Additional Manufacturer Narrative
One photo of product mx4452 was submitted for quality evaluation.Inspection of the photo shows that the there is leakage between the two stopcocks in the construction.The customer complaint of leakage was confirmed.Investigation may be sent to manufacturing.Investigation may be sent to manufacturing.After investigation, the possible root cause of the leak between the tubing and the stopcock could be related to applying solvent to the wrong location on the component due to unclear instructions and a shorter joint resting time by the assembler.A quality alert was created to communicate and reinforce the correct solvent application.Additionally, the work instruction was modified to add an extra container to the operation, to ensure the joint rest time and to correct the assembly instructions to ensure that the solvent is correctly placed in the component.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: 22401349
• Report Number: 9616066-2025-01824
• Device Sequence Number: 8294244
• 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
• 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: 09/30/2025
• 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