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

Catalog Number	2000E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris smartsite needle-free valve was damaged.The following information was provided by the initial reporter: what is happening is the needle-free valve we use to put on the end of our ivs is essentially allowing contrast/saline/blood to leak between it and the iv.Sometimes the iv will blow, sometimes it won't, sometimes techs are randomly hearing a pop sound when flushing saline through by injector to check the iv and two instances a patient heard it too.This was on the same patient, had an iv started in ivr rn area, patient reported she heard a pop and then the saline was leaked out under the tegaderm.So another iv was restarted on the table (the valve would have come from over here in ct) and while it appeared to flush, when the scan was done and a tech went back out to tell her they were done, the contrast had leaked out on the pillows and onto her shirt.She then stated that she heard the pop again when the injection started.I just got word that nlr msc is experiencing issues with them as well with reports of not being able to pull blood back for creatinine.They exchange the valve out with another one, and it will work just fine.When trying to flush saline through, it is harder to push than usual and it will eventually flush but when hooked up to the injector, causes the injector to pressure out.Possible lot #'s: 26025033 23115045 25085822 25085821 26015599 25125536.
Additional Manufacturer Narrative
B.3.The date of event is unknown; bd awareness date used.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: BD ALARIS SMARTSITE NEEDLE-FREE VALVE
• 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.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 25291313
• Report Number: 9616066-2026-01380
• Device Sequence Number: 13153689
• Product Code: FPA
• UDI-Device Identifier: 07613203011938
• UDI-Public: (01)07613203011938
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K223088
• 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): 06/12/2026

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: 2000E
• Device Lot Number: UNKNOWN
• 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: 05/07/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown