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

Catalog Number	2465-0007
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Address was not located, and il was used.Device evaluation: no product or photo was returned by the customer.The customer complaint of component damage - leak could not be verified due to the product not being returned for failure investigation.A device history record review for material# 2465-0007 and lot# 25116247 was performed.The search showed that a total of(b)(4) units in 1 lot number was built on 25 nov 2025.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
It was reported that the bd alaris smartsite pump infusion set was damaged.The following information was provided by the initial reporter: rn noticed the patient's iv epoch bag was leaking.Upon closer inspection, the rn noticed the 0.2 micron filter was cracked.The iv epoch bag was brought down to the central pharmacy, and the chemo technician replaced the infusion set.Item description: set chemo tubing low sorb w/0 mfg #: 2465-0007 lot #: 25116247 quantity affected: 1 ea.Was there injury: reached the individual but did not cause harm.

• Brand Name: BD ALARIS SMARTSITE PUMP INFUSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 25726051
• Report Number: 9616066-2026-01707
• Device Sequence Number: 9439714
• Product Code: FPA
• UDI-Device Identifier: 10885403221941
• UDI-Public: (01)10885403221941(11)251125(17)281124(10)25116247
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2026

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: 2465-0007
• Device Lot Number: 25116247
• 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: 06/12/2026
• Initial Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown