MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS CLOSED MALE LUER; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	2300E-0500
Medical Device Problem Codes	Leak/Splash (1354); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
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 bd alaris closed male luer was separated the following information was received by the initial reporter with the following verbatim it was reported by the customer that the smartsite bag access device was leaking at the connection point where the bag was spiked.The nurse later reported that the device had dislodged from the bag, resulting in a chemotherapy spill.
Additional Manufacturer Narrative
One unopened representative sample was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The sample was spiked into a iv bag.No observation of a leak or disconnection issues were observed.The customer complaint was unable to be verified.The root cause could not be determined because the issue could not be replicated.A device history record review 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 ALARIS CLOSED MALE LUER
• 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: 22948637
• Report Number: 9616066-2025-02639
• Device Sequence Number: 12894092
• Product Code: FPA
• UDI-Device Identifier: 10885403235023
• UDI-Public: (01)10885403235023(17)280501(10)25055024
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K970485
• 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): 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: 2300E-0500
• Device Lot Number: 25055024
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown