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

Catalog Number 5100R

Device Problems Complete Blockage (1094); Restricted Flow rate (1248)

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

Event Date 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.Investigation summary: a 5100r product was not available for investigation; however the customer confirmed that the complaint sample was from lot 18108247.Further information provided by the customer indicates that the occlusion was overcome by connecting and disconnecting from the smartsite several times.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 18108247 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample it is not possible to determine whether a manufacturing defect could have caused or 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 affected product and the connecting product were not returned for investigation, it could not be determined which is the most likely root cause for the customer's experience in this instance.A review of the customer feedback database indicates that this is a rare occurrence with this customer being the only customer to provide this type of feedback against the 5100r product in the past 12 months.

Event Description

It was reported that 2 bd smartsite¿ y-body valve needle-free connectors were occluded during the priming process, but connecting and disconnecting them several times cleared the problem.The following information was provided by the initial reporter, translated from (b)(6) to english: "this is a report about a flow issue (unable to perform priming) from the user (hospital) through (b)(6).According to the user¿s report, a flow issue with smartsite occurred in four cases.The event information is that the hcp could not perform priming; when doing connection and disconnection several times, it worked.".

Event Description

It was reported that 2 bd smartsite¿ y-body valve needle-free connectors were occluded during the priming process, but connecting and disconnecting them several times cleared the problem.The following information was provided by the initial reporter, translated from japanese to english: "this is a report about a flow issue (unable to perform priming) from the user (hospital) through jms.According to the user¿s report, a flow issue with smartsite occurred in four cases.The event information is that the hcp could not perform priming; when doing connection and disconnection several times, it worked.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11/2/2021.H.6.Investigation: four 5100r smartsites were received for investigation without packaging; no connecting products were received to assist the investigation.No further information was received to assist the investigation in this instance.The samples were subjected to functional testing by connecting a 50ml bd plastipak syringe to the received smartsites; in each instance the piston was noted to open and no occlusion or flow restriction was observed.A review of the production records for lot 18108247 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, capa#1998036, 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.H3 other text : see h.10.

• Brand Name: BD SMARTSITE¿ Y-BODY VALVE 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12676620
• MDR Text Key: 277886533
• Report Number: 9616066-2021-52288
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5100R
• Device Lot Number: 18108247
• 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: 11/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2018
• 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