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

Catalog Number	10010483
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris infusion set had flow issues.The following information was received by the initial reporter with the following verbatim it was reported by customer that "while the syringe is infusing you can push the plunger down and it will bolus the medication into the patient despite the rate being set on the pump.".
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
No product or photo was returned by the customer.The customer complaint of flow issues - accuracy could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material 10010483 because the lot number is unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.
Event or Problem Description
Additional information from the customer: the complaint was about the design/functionality of the lvp syringe set in general.They decided not to use the set in clinical practice based on the concerns mentioned in the pir.It was not used on a patient just demonstration prior to possible purchase.Bd marketing team stated i should send this in as a complaint since the customer has a concern about the set design if used in clinical practice.

• Brand Name: BD ALARIS INFUSION SET
• 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: 22049269
• Report Number: 9616066-2025-01287
• Device Sequence Number: 9061474
• Product Code: FPA
• UDI-Device Identifier: 10885403232602
• UDI-Public: (01)10885403232602
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 06/10/2025

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: 10010483
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown