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

Catalog Number	11171447
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date of event is unknown; bd awareness date used.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 the bd alaris smartsite pump infusion set had leakage.The following information was provided by the initial reporter: once 1l bag of fluid was spiked, the line started leaking at the bottom of the drip chamber.Description of product: set alaris 126in 20 dr 3-y 2 luer st 20ea/ca.Lot or s/n: (b)(6).Incident date: unknown.Complaint noticed: during / after use.Problem frequency: 1st time.Patient injury: no.Qty affected: 1 ea.
Additional Manufacturer Narrative
One sample was received for quality evaluation.Priming was attempted on the sample and a leak was identified immediately coming from a crack in the drip chamber.The customer complaint of leakage was confirmed.The investigation was forwarded to the drip chamber supplier group for root cause analysis.After the investigation, the root cause of the issue was determined to be caused by a discontinuity in the molding process.The supplier has indicated that the component is subjected to statistically controlled examination 3 times per shift and the issue appears to be a single event.No further actions we implemented due to the extensive quality controls already in place but the issue will be monitored for further reports of the issue.A device history record review for model 11171447 lot number 25065203 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: 23627954
• Report Number: 9616066-2025-03563
• Device Sequence Number: 9317110
• Product Code: FPA
• UDI-Device Identifier: 07613203021234
• UDI-Public: (01)07613203021234(17)280606(10)25065203
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

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: 11171447
• Device Lot Number: 25065203
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 11/23/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown