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

Catalog Number 2000E

Device Problems Complete Blockage (1094); Restricted Flow rate (1248); Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/17/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: three 2000e (b)(4) samples were received for investigation, two in opened packaging from lot 21045802 and one was received without packaging.No connecting products were received t assist the investigation in this instance.Functional testing was performed by connecting a bd plastipak 50ml syringe to the received samples.It was observed for all three samples, the piston of the smartsite opened and no occlusion was observed.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 21045802 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.In this instance, a definitive root cause could not be identified as testing of the returned samples did not identify any product defects that could have contributed to the customer¿s experience.However following a small number of similar reports, bd has conducted an in-depth investigation to identify any potential contributing factors for occlusion of this nature.The investigation has determined that a potential contributor could be the result of an insufficient amount of fluorosilicone having been injected into the piston of the smartsite during the assembly process; fluorosilicone is used as a lubricant within the smartsite to ensure the consistent opening of the piston when the smartsite is activated, and an insufficient amount may cause a temporary occlusion.Please note previous investigations have also determined that features on the surface of the male luer of the connecting products may also contribute to the reported occlusion.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.In this instance as the reported occlusion was not replicated during testing of the returned samples, and the connecting products were not returned as part of the investigation it could not be determined which is the most likely root cause for the customer's experience in this instance.Please note, in order to minimize reports for occlusions of this nature, the manufacturing site has repaired the assembly machine to ensure that an adequate amount of fluorosilicone is injected into each smartsite.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the 2000e (b)(4) set in the past 12 months.

Event Description

It was reported when using the bd alaris smartsite needle-free valve there were flow issues, blocked device, and a damage/broken device.The flow issue event occurred 4 times.The damaged product issue occurred 1 time.The following information was provided by the initial reporter.The customer stated: "in vascular surgery, blocked tubes and broken interfaces were found when the product was used.".

• Brand Name: BD 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12824361
• MDR Text Key: 282567464
• Report Number: 9616066-2021-52429
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203011938
• UDI-Public: 07613203011938
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/16/2024
• Device Catalogue Number: 2000E
• Device Lot Number: 21045802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2021
• 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