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

Model Number 2000EA

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/13/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: a photo of the smartsite was provided by the customer.A crack in the smartsite could not be identified in the photo.The customer complaint of component damage - leak could not be verified with the photo provided.A device history record review for model 2000ea, lot number 21035207 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 02mar2021 there were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.No product will be returned per customer.No investigation was performed.

Event Description

It was reported that the bd smartsite needle-free valve experienced device damage while still considered operable.The following information was provided by the initial reporter: leaking of blood between the smartsite and their microclave.We believe it was either a crack in the smartsite or the microclave.

• Brand Name: BD 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: 13203932
• MDR Text Key: 286570508
• Report Number: 9616066-2021-52708
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 27613203021689
• UDI-Public: 27613203021689
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/02/2024
• Device Model Number: 2000EA
• Device Catalogue Number: 2000EA
• Device Lot Number: 21035207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1