MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. TEXIUM; SYRINGE, PISTON

Catalog Number	MY8060
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.More than one 510k is applicable, k231888.
Event or Problem Description
It was reported occlusion with texium.Additional information.Delay in compounding process, this short tubing set with the texium access would not let the technician push any drug through and they had to get a new iv bag and tubing set to finish the prep.No patient impacts.
Additional Manufacturer Narrative
Investigation results: due to no sample being received, an investigation could not be performed, and a root cause could not be determined.No product will be returned per customer.No investigation was performed.
Event or Problem Description
It was reported that they had to open three syringes before they could get one that was functioning.The syringes could not transfer anything into the vials.Delay in compounding process, as the technician could not pull anything through the syringes, and it was not the topper, the tech finally got a good syringe, and it went fine.No patient impacts.

• Brand Name: TEXIUM
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• 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: 24641105
• Report Number: 9616066-2026-00714
• Device Sequence Number: 9876305
• Product Code: FMF
• UDI-Device Identifier: 10885403221699
• UDI-Public: (01)10885403221699(17)280331(10)25045036
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K071108
• 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): 03/30/2026

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: Health Professional
• Device Catalogue Number: MY8060
• Device Lot Number: 25045036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 03/29/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown