MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. LL VLV ADPT(STAND ALONE); SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2000E CHINA
Medical Device Problem Code	Blocked Connection (2888)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported, ll vlv adpt(stand alone), the infusion flow was obstructed.Upon disconnecting the infusion set, it was discovered that the tubing of the infusion connector was blocked.Use was immediately discontinued, and a new infusion connector was installed.
Additional Manufacturer Narrative
A 2000e china product was not available for investigation of pr 14935449; however, in this instance customer provided lot number was incorrect.The feedback provided by the customer states that, "the infusion flow was obstructed".No further information was available to assist the investigation in this instance.The details of this feedback were forwarded to the manufacturing site for investigation; however, the lot number provided by customer was incorrect and therefore it is not possible to perform a review of the production documentation for this particular product.The root cause of the customer¿s experience could not be determined in this instance as no sample was received for investigation.Without a sample to examine it is not possible to determine whether a manufacturing defect could have caused or contributed to a report of this nature.However, previous complaints for occlusions have been related to features on the surface of the male luer of the connecting products.These features include flash or a raised edge to the tip of the male luer which have previously been shown to intermittently lead to restricted flow due to them pinching the blue piston of the smartsite and not allowing it to open.This can sometimes be resolved by disconnecting and reattaching the same luer connection which may reposition the luer against the piston and improve the flow, or alternatively by changing the connecting male luer.

• Brand Name: LL VLV ADPT(STAND ALONE)
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 25172971
• Report Number: 9616066-2026-01279
• Device Sequence Number: 13307451
• Product Code: FPA
• UDI-Device Identifier: 07613203011938
• UDI-Public: (01)07613203011938(10)20250610
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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 CHINA
• 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: 04/30/2026
• Initial Report FDA Received Date: 05/14/2026
• 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