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	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 bd alaris smartsite texium secondary set was separated.The following information was received by the initial reporter with the following verbatim.It was reported by customer that chemo secondary tubing fell apart.
Additional Manufacturer Narrative
The customer reported tubing fell apart, and returned 3 used, and one unopened samples of material 10013364t, lot 22109056.A total of 4 samples were returned.Upon initial visual examination, the sets verified the complaint of separation at the drip chamber.The 3 sets that were open/used were all separated, the one representative, unopened sample did not separate.The gives a total failure count of 3 samples.The samples were examined under a microscope and insufficient solvent was found at the tubing/drip chamber connections of the 3 used sets.The manufacturing plant found the root cause for the separation issue to be related to incorrect solvent application during assembly.A device history record review was performed, and this lot was released 04oct2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The plant upgraded the solvent dispenser from medegen to medica, under an engineering change on (b)(6) 2023 in addition, a solvent dispenser fixture was added under an engineering change record, and was released on june 25th, 2024 to assure the correct assembly between the tubing/drip chamber.

• 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: 21412603
• Report Number: 9616066-2025-00284
• Device Sequence Number: 9318135
• Product Code: FPA
• UDI-Device Identifier: 10885403198915
• UDI-Public: (01)10885403198915(11)221004(17)251004(10)22109056
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/11/2025

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: 10/04/2025
• Device Catalogue Number: 10013364T
• Device Lot Number: 22109056
• 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: 01/30/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 04/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown