MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SMARTSITE¿ NEEDLE-FREE CONNECTOR, PRIMING VOLUME 0.11 ML; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 2000E-04

Device Problem Improper Flow or Infusion (2954)

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

Event Date 02/28/2023

Event Type  malfunction  

Event Description

It was reported while using bd smartsite¿ needle-free connector, priming volume 0.11 ml there were flow issues.There was no report of patient impact.The following information was provided by the initial reporter: our customers are experiencing a fault with the smart site bungs again.The fault is only noted when injecting volume under pressure, the bung causes a pressure alarm due to the flow construction caused by the bung.The problem is occlusion with the contrast boluses given.This was given at 6ml per minute.

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd smartsite¿ needle-free connector, priming volume 0.11 ml there were flow issues.There was no report of patient impact.The following information was provided by the initial reporter: our customers are experiencing a fault with the smart site bungs again.The fault is only noted when injecting volume under pressure, the bung causes a pressure alarm due to the flow construction caused by the bung.The problem is occlusion with the contrast boluses given.This was given at 6ml per minute.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 02-may-2023.Investigation summary: two 2000e-04 samples from lot 22055097 were received in sealed packaging for investigation.The feedback provided by the customer suggests a complete occlusion was detected during use of the smartsite device.No connecting products were received to assist the investigation in this instance.A visual inspection of the returned samples did not identify any obvious damages or manufacturing issues which could have caused or contributed to the customer's experience.Functional testing was performed by connecting the returned samples to a 50ml bd plastipak syringe and attempting to flush with fluid; in each instance, the piston of the smartsite opened and no occlusions or flow restrictions were detected.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 22055097 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.It was not possible to confirm the root cause of the customer¿s experience in this instance, as testing of the returned sample did not identify any product defects or quality deviations that could have contributed to the customer¿s experience.Previous complaints for occlusions have been related to features on the surface of the male luer of the connecting products.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 neither the complaint products or connecting products were provided to assist the investigation.

• Brand Name: BD SMARTSITE¿ NEEDLE-FREE CONNECTOR, PRIMING VOLUME 0.11 ML
• 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: 16569912
• MDR Text Key: 312052772
• Report Number: 9616066-2023-00488
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 20885403480925
• UDI-Public: (01)20885403480925
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2000E-04
• Device Lot Number: 22055097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2022
• 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