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	03/28/2026
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, translated from chinese to english: a patient underwent catheter-based treatment at a (b)(6) oncology center and was discharged home with the catheter in place.While at home, the catheter connector fractured; upon presenting to a local facility for replacement, the staff there stated they were unable to handle the procedure.Consequently, the head nurse expressed concern regarding the patient's risk of infection.This specific department within the hospital has recently experienced multiple incidents involving the fracture of "2000e china" catheters, with the fracture sites being nearly identical in almost every case.Based on the information gathered to date: 1.Fractures have occurred in both competitor products and bd's own picc catheters.There is no discernible consistency across the specific batches of "2000e china" catheters involved in these fractures.2.No correlation has yet been established between the duration of catheter indwelling and the occurrence of fractures; in other words, fractures have occurred regardless of whether the catheter had been in place for a short or long period.Furthermore, the circumstances surrounding these incidents vary: some fractures occurred while the patient was hospitalized, while others occurred during the patient's time at home.3.Customers have indicated that utilizing our "maxzero" connector system appears to yield better results.However, due to various factors, transitioning to this alternative system presents certain practical difficulties.
Additional Manufacturer Narrative
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: 24972272
• Report Number: 9616066-2026-01092
• Device Sequence Number: 11974405
• Product Code: FPA
• UDI-Device Identifier: 07613203011938
• UDI-Public: (01)07613203011938
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K223088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2026

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: 03/28/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 05/19/2026
• 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