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

Catalog Number 2000E CHINA

Device Problem Obstruction of Flow (2423)

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

Event Date 05/04/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: five 2000e china samples from lot 22035026 were received for investigation ; two samples were received without packaging and three samples were received in sealed packaging for investigation.The feedback provided by the customer suggests occlusion was detected during use of the smartsite device.A visual inspection of the returned samples did not identify any obvious damage or manufacturing issues which could have caused or contributed to the reported occlusion.Functional testing was performed by connecting the smartsite devices to a 50ml bd plastipak syringe from stock and attempting to flush with fluid; in each instance, the piston of the smartsite opened and no occlusions or flow restrictions were detected throughout testing.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 22035026 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.A definitive root cause for the customer's experience could not be determined as no occlusion or flow restriction was observed during testing of the returned samples.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 connecting product was not returned for investigation it was not possible to determine whether this may have contributed to the customer's experience.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the smartsite component in the past 12 months.

Event Description

It was reported that rubber plug in the bd smartsite¿ needle-free connector would not move and blocked the flow.This occurred with 5 connector sets during use.The following information was provided by the initial reporter, translated from chinese: "when the joint is in use, the rubber plug will not move.".

• Brand Name: BD SMARTSITE¿ NEEDLE-FREE CONNECTOR
• 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 ; 8448235433
• MDR Report Key: 17007989
• MDR Text Key: 316004208
• Report Number: 9616066-2023-01019
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 05/05/2023

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
• Device Operator: Other
• Device Catalogue Number: 2000E CHINA
• Device Lot Number: 22035026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2022
• 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