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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SMARTSITE NEEDLE-FREE CONNECTOR NEEDLELESS CONNECTOR

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SMARTSITE NEEDLE-FREE CONNECTOR NEEDLELESS CONNECTOR Back to Search Results
Catalog Number 2000E-04
Device Problems Partial Blockage (1065); Complete Blockage (1094)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/25/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: six 2000e-04 samples were received in opened packaging from lot 20116583 for investigation. No connecting products were received to assist the investigation. A visual inspection of the returned samples 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 retained stock to the returned samples; in each instance 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 20116583 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. 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 4 smartsite needle-free connector experienced flow issues. The following information was provided by the initial reporter: the luer appears blocked - you can't flush it or drawer blood out of it. Fault is intermittent - not with all luers. Staff member tried 3 luers and couldn't use any of them, then with the 4th luer with a lot of force managed to get it to work.
 
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Brand NameSMARTSITE NEEDLE-FREE CONNECTOR
Type of DeviceNEEDLELESS CONNECTOR
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 Key12247713
MDR Text Key266195515
Report Number9616066-2021-51646
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2000E-04
Device Lot Number20116583
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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