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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; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SMARTSITE NEEDLE-FREE CONNECTOR; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 2000E-04
Device Problems Complete Blockage (1094); Restricted Flow rate (1248)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/30/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that saline would not flush through the smartsite needle-free connector when connected with the syringe.This occurred 5 separate times during use.The following information was provided by the initial reporter: "smartsite connected to luer-ock syringe with saline but would not flush.This has occurred on 4 other occasions this week.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10/d11: concomitant medical products: device available for eval yes.D10/d11: concomitant medical products: returned to manufacturer on: 2020-12-23.H6: investigation summary: two 2000e-04 samples were received for investigation with an opened packaging from lot 20065103.Additionally a 10ml bd syringe with residual fluid was received connected to one of the samples to assist the investigation.A visual inspection of the samples did not identify any signs of damage or manufacturing defects which could have contributed to the customer's experience.Functional testing was performed by separately connecting each sample to the received 10ml syringe and flushing with fluid; no flow restriction or occlusion was observed throughout testing.The test was then repeated using a 50ml bd plastipak syringe from stock again no flow restrictions or occlusions were observed.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 20065103 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 reported issue in this instance.Testing of the returned sample did not identify any product defects or quality deviations that could have contributed to the customer¿s experience.A review of the customer feedback database indicates that reports of this nature against the standalone smartsite device occur at a low frequency and have not been attributable to a product defect or manufacturing issue.H3 other text : see h.10.
 
Event Description
It was reported that saline would not flush through the smartsite needle-free connector when connected with the syringe.This occurred 5 separate times during use.The following information was provided by the initial reporter: "smartsite connected to luer-ock syringe with saline but would not flush.This has occurred on 4 other occasions this week.".
 
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Brand Name
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 22244
MX  22244
MDR Report Key11091442
MDR Text Key224798481
Report Number9616066-2020-20673
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 01/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/02/2023
Device Catalogue Number2000E-04
Device Lot Number20065103
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2020
Date Manufacturer Received01/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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