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 Codes	Leak/Splash (1354); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch #: 24109021, 24079174.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 damaged.The following information was received by the initial reporter with the following verbatim: it was reported by customer that drug came out from pharmacy with bonded texium tubing as usual.Rn was wearing complete ppe but had a thought to put a chemo absorbent pad directly underneath the area of intended connection (as we have communicated to staff to be extra careful now).Rn correctly connected bonded texium tubing to upper y-site alaris tube connection as usual practice.Rn involved reports there was no resistance or indication that the connection or process of screwing in the texium cap into the y-site was done incorrectly or broken.Infusion rn reports approximately 10 seconds later; she noted that the bevacizumab was leaking drops from the concerned site onto the chemo absorbent pad.
Additional Manufacturer Narrative
One sample lot 24109021 and one sample lot 24079174 was returned for investigation.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The sets were primed with water and no leaks were observed.The sets were pressurized at 30 psi for 10 minutes.A leak was observed for lot 24109021 at the connection to the extension set.A leak was seen at the texium to male luer connection.The customer complaint was verified.A device history record review 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
No additional information.

• 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: 21370686
• Report Number: 9616066-2025-00222
• Device Sequence Number: 20973447
• Product Code: FPA
• UDI-Device Identifier: 10885403198915
• UDI-Public: (01)10885403198915(11)240703(17)270703(10)24079174
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/17/2025

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: 10013364T
• Device Lot Number: 24079174
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown