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

Catalog Number	10013364T
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris smartsite texium secondary set was damaged the following information was received by the initial reporter with the following verbatim.It was reported by customer that code orange with secondary set.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of tubing defective / damaged could not be verified due to the product not being returned for failure investigation.A device history record review for material # 10013364t and lot # 22079325 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 16jul2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

• Brand Name: BD ALARIS SMARTSITE TEXIUM 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: 22536675
• Report Number: 9616066-2025-02030
• Device Sequence Number: 8017673
• Product Code: FPA
• UDI-Device Identifier: 10885403198915
• UDI-Public: (01)10885403198915
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 07/03/2025

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 Expiration Date: 07/22/2025
• Device Catalogue Number: 10013364T
• Device Lot Number: 22079325
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown