MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD 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	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd smartsite bag access device was damaged the following information was received by the initial reporter with the following verbatim it was reported by the customer that while using the product towards the end of sterile compounding, there were two occurrences of spikes breaking from the luer lock connection causing medication to leak onto the work surface of the compounding hood.The third spike broke during the beginning of sterile compounding.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
The customer reported vial access devices are breaking, and returned photos as well as one unopened sample of material 2300e-0500, lot 24026410.Upon initial visual examination, the set verified the complaint of component damage.The photos both verify a break at the connection of the smart site, and the vial access spike component, with cracked and stressed plastic where it severed.The unopened sample returned also verified component damage, but of a completely different type.The flat handle on the device, had been severed and half of the plastic piece was broken off, and not even included in the packaging.The manufacturing site found a root cause for both of the issues.For the break at smart site connection site, the root cause was unable to be traced to the manufacturing site.There was a previous complaint record where an action was done to address failures of this type on material 2300e-0500.The spike press machine used during assembly was updated to ensure the proper preventative maintenance was done to ensure proper use.This action was done after the release of the lot reported.For the break of the device flange, the root cause was unable to be traced to the manufacturing process.The root cause is potentially related to excessive force applied to the device.No actions at the plant were taken to address this failure, without a verified root cause.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 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: 23538367
• Report Number: 9616066-2025-03464
• Device Sequence Number: 10055505
• Product Code: FPA
• UDI-Device Identifier: 10885403235023
• UDI-Public: (01)10885403235023(17)270227(10)24026410
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K970485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: 24026410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown