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

Catalog Number	10016073
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris smartsite pump infusion set had foreign matter in the fluid path.The following information was provided by the initial reporter: staff opened new package and spots of brown noticed throughout the drip chamber.Additional information received from the customer: can you please provide an exact date of event in this format mm-dd-yyyy? the date the set was discovered was 09-18-2025.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.When staff discovered possible contaminated set the secondary set was not used and therefore no pt harm/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 sample was received for quality evaluation.Inspection of the sample shows that there is foreign matter within the drip chamber of the sample.The customer complaint of foreign matter was confirmed.The investigation was forwarded to the supplier for root cause analysis.After the investigation at the supplier, the foreign matter is determined to be embedded degraded material of the drip chamber.This is a cosmetic issue that can happen during injection molding process of the soft pc chamber.The soft pvc material is a very sensible material to the degradation.It is also possible that the embedded degraded material is already in the grains of the raw material.Verification of the parts produced within the same lot was conducted and no parts with embedded material detected.Additionally, records of cleaning of the plasticization group of the molding machine was reviewed and all were done according to the scheduling.The possible root cause is a discontinuity in the manufacturing process that can have generated the defective part.A device history record review for model 10016073 lot number 25043135 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: 23987035
• Report Number: 9616066-2025-04109
• Device Sequence Number: 10606346
• Product Code: FPA
• UDI-Device Identifier: 10885403230110
• UDI-Public: (01)10885403230110(11)250403(17)280402(10)25043135
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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: 10016073
• Device Lot Number: 25043135
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown