MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS SMARTSITE BAG ACCESS DEVICE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	2300E-0500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
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 smartsite bag access device was broken.The following information was received by the initial reporter with the following: it was reported by the customer that the spike broke off from the access point after the blood bag was spiked.Broken piece in bag with intact piece for reference.Once broken, spilled blood and could not get out of spike port.
Additional Manufacturer Narrative
The customer reported the smart site broke off from the spike, and returned one used, broken device, and one unopened device.The devices were both of material 2300e-0500, lot 24025033.Upon initial visual examination, the unopened set had no defects or abnormalities.The used, broken device verified the complaint.The smart site was the only part of the device returned.The spike was not available.The smart site was examined under a microscope to see the cracking of the plastic.The manufacturing plant could not find the root cause for the smart site damage and was unable to replicate the failure in the current process.An action to perform preventative maintenance was issued by the plant on 31jul2024 (this batch was released before the action, on 07feb2024).The maintenance updated the spike press in the assembly and ensures the equipment is in optimal usage conditions.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 SMARTSITE BAG ACCESS DEVICE
• 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: 21543524
• Report Number: 9616066-2025-00457
• Device Sequence Number: 17917068
• Product Code: FPA
• UDI-Device Identifier: 10885403235023
• UDI-Public: (01)10885403235023(11)240201(17)270201(10)24025033
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/09/2025

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: 24025033
• 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: 02/17/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown