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	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 kinked tubing.The following information was provided by the initial reporter: 6/10/25 - could not get the fluids or medications to flow.Untucked the arms and found the iv tubing kinked.This was a carotid case that had nitroglycerin and levophed that was being administered.Additional information received from the customer: is the lot number known? no were there any adverse events associated with this incident? delay of treatment in a critical case.
Additional Manufacturer Narrative
One photo of product mx4452 was submitted for quality evaluation.Inspection of the photo shows that the infusion set tubing was kinked.Further analysis indicates that even though the tubing was kinked, there appears to be fluid on both sides of the tubing kinks.The customer complaint of tubing kinked was confirmed.Investigation may be forwarded to manufacturing for further analysis.After review of the information submitted, it was determined that the issue could not be a manufacturing issue.Additionally, the photo provided was not sufficient enough to determine a root cause, confirm excess solvent, or if the set was coiled correctly.The root cause for the issue could not be determined.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: 22401262
• Report Number: 9616066-2025-01822
• Device Sequence Number: 9977967
• 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: 09/24/2025
• 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