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

Catalog Number 2000E-04

Device Problems Backflow (1064); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/26/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 3 alaris smartsite needle-free valves experienced blood backflow during infusion, and leakage. The following information was provided by the initial reporter: as discussed our staff have reported problems with smart site connectors. Problems are blood leaking back (quite significant) or blockages. This morning¿s leaking blood episode followed a small blood sample taken with 2ml syringe and then complete failure of the valve resulting in blood flowing back.

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 3 alaris smartsite needle-free valves experienced blood backflow during infusion, and leakage. The following information was provided by the initial reporter: as discussed our staff have reported problems with smart site connectors. Problems are blood leaking back (quite significant) or blockages. This morning¿s leaking blood episode followed a small blood sample taken with 2ml syringe and then complete failure of the valve resulting in blood flowing back.

• Brand Name: ALARIS SMARTSITE NEEDLE-FREE VALVE
• Type of Device: 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13063081
• MDR Text Key: 286346230
• Report Number: 9616066-2021-52632
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 2000E-04
• Device Lot Number: 21046253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial