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

Catalog Number	37262E
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 extension set was separated the following information was received by the initial reporter with the following verbatim it was reported by customer that there was no action happening during the break.It had been attached to the primary tubing and to the patient.The tubing pulled apart at the site in the picture 4833 in the bottom left of the image and then blood came back into the tubing (so they couldn't save that piece to give to me - 4834 is a new product with the image of what got disconnected.
Additional Manufacturer Narrative
Two samples model 37262e was returned for investigation.The sets were examined for defects and abnormalities.The sets were separated at the inlet port of the distal y-site.No other defects or abnormalities were observed.The customer complaint was verified.From the manufacturer's investigation, the possible root cause of separation between tubing/y-site (arm) could be related to lack of solvent due to incorrect solvent application by the operator or issues with the solvent dispenser.No additional actions were taken since reported sku was deactivated in hermosillo site and production of this sku was reactivated in tj site.A device history record review was performed on the possible lots.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD ALARIS SMARTSITE EXTENSION 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: 23389110
• Report Number: 9616066-2025-03266
• Device Sequence Number: 9844501
• Product Code: FPA
• UDI-Device Identifier: 10885403235276
• UDI-Public: (01)10885403235276
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 01/22/2026

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: Other
• Device Catalogue Number: 37262E
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 01/22/2026
• 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