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

Catalog Number	MX9433
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
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 with needleless y-site was damaged the following information was received by the initial reporter with the following verbatim it was reported by customer that tubing came apart into two pieces at the lowest port when they tried to pull the clamp.
Additional Manufacturer Narrative
One sample was received for quality evaluation.Visual evaluation was conducted and it was noted that the sample tubing was separated from an inlet port to a y-site smartsite connector.The customer complaint of separation - no leak was verified.The investigation was forwarded to manufacturing for root cause evaluation.After the investigation, the potential root cause for the separation between the tubing and nac-y (arm) could be related to an incorrect solvent application by the assembler or issues with the solvent dispenser.The reported product line production will be moved to a different manufacturing location and therefore corrective actions to the assembly process that produced this product will not be conducted.We will continue to track and trend and if any negative trend is observed, proper actions will be deemed necessary for the next scheduled production at the new manufacturing site.A device history record review for model mx9433 lot number 24089254 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE
• 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: 21455120
• Report Number: 9616066-2025-00331
• Device Sequence Number: 4604427
• Product Code: FPA
• UDI-Device Identifier: 10885403237782
• UDI-Public: (01)10885403237782(11)240812(17)270812(10)24089254
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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: MX9433
• Device Lot Number: 24089254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown