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

Catalog Number	2000EA
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that four bd smartsite needle-free valve experienced occlusion.The following information was provided by the initial reporter: seasoned nurses have had difficulty in flushing through the smart site, this happened at least three times over the last several weeks and is a concern.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that four bd smartsite needle-free valve experienced occlusion.The following information was provided by the initial reporter: seasoned nurses have had difficulty in flushing through the smart site, this happened at least three times over the last several weeks and is a concern.
Additional Manufacturer Narrative
H6: investigation summary 1 unused sample for model 2000ea lot number# 20105313 was returned for investigation.The set was examined for defects and abnormalities for flow issues.No defects or abnormalities were observed.The set was attached to a cut off bd syringe to see if a fluid path can be observed.A fluid path was observed clearly.The smartsite was then connected to a 10 ml bd syringe filled with water and the smart site set was attempted to be flushed.The set was successfully flushed.The customer complaint that the smart site are difficult to flush could not be replicated.A device history record review for model 2000ea and lot number 20105313 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 16oct2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot.The root cause of flow issues - fluid blockage could not be determined because the issue could not be replicated.A trend for this occlusion issue has been identified for this product line.A capa (corrective action preventative action) 1998036 has been initiated, and a team has been assembled in order to investigate the issue.

• Brand Name: BD SMARTSITE NEEDLE-FREE VALVE
• Common Device Name: 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: 15033578
• Report Number: 9616066-2022-00894
• Device Sequence Number: 12498366
• Product Code: FPA
• UDI-Device Identifier: 07613203012751
• UDI-Public: 07613203012751
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 07/26/2022

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: Health Professional
• Device Expiration Date: 10/13/2023
• Device Catalogue Number: 2000EA
• Device Lot Number: 20105313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown