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

Catalog Number	20059E
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2026
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 the bd alaris smartsite extension set had connection issues.The following information was provided by the initial reporter: extension set will not pull blood back.Iv was started and had blood return.Extension set was connected with vacutainer and labs would not draw back.When extension set was removed, blood starts coming out of the insyte autoguard.If a flush or syringe is hooked up to the line instead of the vacutainer, there are no problems aspirating back for blood and the extension set works properly.The smartsite valve extension set seems to come sealed on the valve end from the manufacturing plant.In order to break this seal, a flush needs to be hooked up and the line needs to be primed with saline prior to use.We observed the lab draw practice on the l&d unit and identified that the clinicians direct connecting a vacutainer before a flush/syringe were the ones experiencing issues.The vacutainer thread is not deep enough to break the seal (2 thread counts).The flush syringe has an extra thread (3 thread counts), making it a deeper connection to break the seal.

• Brand Name: BD ALARIS SMARTSITE EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• 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 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 25459885
• Report Number: 9616066-2026-01523
• Device Sequence Number: 21445182
• Product Code: FPA
• UDI-Device Identifier: 07613203012317
• UDI-Public: (01)07613203012317(11)251119(17)281118(10)25116104
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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: Other
• Device Catalogue Number: 20059E
• Device Lot Number: 25116104
• 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: 05/20/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 06/10/2026
• Supplement Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown