MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS SMARTSITE TEXIUM LOW SORBING SECONDARY SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	4030B-07T
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 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 bd alaris smartsite texium low sorbing secondary set had air in line the following information was received by the initial reporter with the following verbatim it was reported by customer that the tubing pulling air caused air in line error but there was still fluid in the drip chamber.
Additional Manufacturer Narrative
One sample was received for quality evaluation.Visual inspection was conducted and no damages or abnormalities were identified.The sample was primed with water and monitored to identify any issues.There was no air-in-line, leakage or occlusion identified.The customer complaint of air bubble / air in line could not be replicated.A root cause for the reported failure was not determined because the failure was not replicated.A device history record review for model 4030b-07t lot number 24059484 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
Material # 4030b-07t batch #24059484 it was reported by customer that the tubing pulling air caused air in line error but there was still fluid in the drip chamber verbatim: rcc received a complaint via community.Pir attached tubing pulling air caused air in line error but there was still fluid in the drip chamber product number - 4030b-07t customer responded on 17-feb-2025 1.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.No known harm 2.Please provide the address of the facility for us to ship the return label? have the previous issues been reported to bd? if so, please provide the complaint reference number.If not, kindly answer the following questions: 1.Could you please provide the exact date of the event in the format mm-dd-yyyy? the date of submission would be the date it occurred - i submitted 2 issues and i'm not sure which one this is or what date it happened 2.Please share the material and lot number associated with the reported issue.This was included in the report - i no longer have this information.3.Describe any patient harm, injury, complication, or negative outcome that occurred as a result of the event.No known harm 4.Is there a physical sample available for investigation? if yes, please provide the address of the facility so we can send the return label.Yes, but drug is present - possibly chemotherapy (depending on which complaint).Product is currently double bagged to prevent spillage.

• Brand Name: BD ALARIS SMARTSITE TEXIUM LOW SORBING SECONDARY 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: 21529833
• Report Number: 9616066-2025-00425
• Device Sequence Number: 20916453
• Product Code: FPA
• UDI-Device Identifier: 10885403240867
• UDI-Public: (01)10885403240867(11)240528(17)270528(10)24059484
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2025

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: 4030B-07T
• Device Lot Number: 24059484
• 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: 02/13/2025
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown