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

Catalog Number 2000E-04

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

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

Event Date 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: one hundred 2000e-04 samples were received in sealed packaging from lot 20115184.No connecting products were received to assist the investigation.A sample size of fifteen 2000e-04 products were randomly selected for testing.Functional testing involved connecting the received samples to a 50ml bd plastipak syringe from stock and attempting to flush each smartsite.Upon connection to the syringe, the piston of the smartsite opened for all fifteen samples and no flow restrictions or occlusions were identified.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 20115184 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 smartsite.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, 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-04 product in the past 12 months.

Event Description

It was reported that 81 bd smartsite¿ needle-free connectors had flow issues and were blocked/occluded during use.The following information was provided by the initial reporter: "when used in conjunction with go medical 3 way extension set, pump would alarm for flow or pressure.".

• 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
• MDR Report Key: 12586568
• MDR Text Key: 275209292
• Report Number: 9616066-2021-52174
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 09/10/2021

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: Other
• Device Expiration Date: 11/02/2023
• Device Catalogue Number: 2000E-04
• Device Lot Number: 20115184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 10/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2020
• 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