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 Partial Blockage (1065)

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

Event Date 09/26/2021

Event Type  malfunction  

Event Description

It was reported that 5 bd smartsite¿ needle-free connectors were blocked during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "on (b)(6) 2021, when the nurse connected the infusion connector to the indwelling needle for the patient's infusion, and found that the infusion was blocked, then the connector was removed and the syringe was still not working.It was confirmed that the problem was the infusion connector and not the indwelling needle.Later changed the prn for injection.The nurse reported that the infusion connector has encountered similar conditions four times, affecting the nurse's operation and possibly allowing the patient to undergo multiple venipuncture.".

Manufacturer Narrative

Investigation summary: one 2000e (b)(6) sample was received without packaging for investigation, however the customer indicated that the complaint sample was from lot 21045808.No connecting products were returned to assist the investigation; however the customer indicates that the occlusion was identified during connection with a zhejiang lingyang syringe.A visual inspection of the returned smartsite components did not identify any product defects or manufacturing issues which could have contributed to the customer's experience.Functional testing was performed by connecting a retained 50ml bd plastipak syringe from stock to the returned sample; no flow restrictions or occlusions were identified during testing.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 21045808 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 smartsites.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 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.However in this instance no occlusion 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, and the reported occlusion was not replicated during testing of the returned samples 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)(6) product in the past 12 months.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12776487
• MDR Text Key: 280521657
• Report Number: 9616066-2021-52385
• 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: 10/20/2021

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: Health Professional
• Device Expiration Date: 04/27/2024
• Device Catalogue Number: 2000E CHINA
• Device Lot Number: 21045808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/09/2021
• 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