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

Catalog Number	10015861A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris smartsite pump infusion set had leakage.The following information was provided by the initial reporter: tubing was leaking below the y-site.No adverse events or injury.
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
One photo was received for quality evaluation.Inspection of the photo indicates that the tubing set was leaking at the inlet port of a y-site smartsite.The customer complaint of leakage was confirmed.The investigation was forwarded to manufacturing for root cause analysis.After the investigation along with the manufacturing and quality operations team, picture evidence the leakage in the tubing/y-site arm engagement, however, photo does not give us enough evidence to define a potential root cause that generates condition reported.This condition may be related to a lack of solvent in the tubing and/or a issue in the insertion of the tubing by the production personnel.No actions were taken for this complaint since picture evidence the leakage reported but it does not give us enough evidence to define a potential root cause.However, improvements will be implemented to the manufacturing process updating the frequency control record for the assembly lines.A device history record review for model 10015861a lot number 25055230 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 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.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23297228
• Report Number: 9616066-2025-03098
• Device Sequence Number: 10192791
• Product Code: FPA
• UDI-Device Identifier: 10885403232626
• UDI-Public: (01)10885403232626(17)280508(10)25055230
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• 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): 01/30/2026

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: 10015861A
• Device Lot Number: 25055230
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown