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

Catalog Number 2000E7D

Device Problem Backflow (1064)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/05/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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 the bd smartsite¿ needle-free valve caused blood to back-flow during the infusion.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "staff in medical decisions unit at hospital describe three seperate incidents when they attach the bung to the cannula they are back flowing and causing increased pressure and bleeding.Three incidents occured over 24 hours on (b)(6) 2023.Staff utilised uss and pathology gas analysis to rule out the likely hood or arterial cannulation instead of venous.On each occasion it was a vein that was cannulated.No injury to staff or patients reported or blood exposure incidents.".

Manufacturer Narrative

H.6.Investigation summary: no samples were received for investigation of (b)(4), in which the customer has stated: "when they attach the bung to the cannula they are back flowing and causing increased pressure and bleeding." this feedback is in reference to 2000e7d products from lot 1024444.Further correspondence with the customer clarified the issue further, as it was stated: "the staff were flushing the bungs on all 3x occasions and the syringes of n.Saline were filling up with blood." there were no reports of any damage or deformity to the smartsite components.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 1024444 did not identify any in-process testing failures or quality deviations which may have caused or contributed to a report of this nature.Please note that the 2000e7d product is not a back check valve and therefore during use it may be possible for back flow to occur under certain infusion rates and clinical set-ups.When the smartsite component is accessed with a compatible male luer, it is effectively an open path, through which fluid can travel in both directions; however, when the connecting product is removed, it becomes a closed system.A review of the customer feedback database indicates that complaints of this nature are rare and there is currently no trend for issues of this nature against the 2000e7d product.

Event Description

It was reported that the bd smartsite¿ needle-free valve caused blood to back-flow during the infusion.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "staff in medical decisions unit at hospital describe three separate incidents when they attach the bung to the cannula they are back flowing and causing increased pressure and bleeding.Three incidents occured over 24 hours on (b)(6) 2023.Staff utilised uss and pathology gas analysis to rule out the likely hood or arterial cannulation instead of venous.On each occasion it was a vein that was cannulated.No injury to staff or patients reported or blood exposure incidents.".

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17808574
• MDR Text Key: 324156105
• Report Number: 9616066-2023-01939
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• 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: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2000E7D
• Device Lot Number: 1024444
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2022
• 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