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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SMARTSITE¿ NEEDLE-FREE CONNECTOR, PRIMING VOLUME 0.11 ML; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SMARTSITE¿ NEEDLE-FREE CONNECTOR, PRIMING VOLUME 0.11 ML; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 2000E CHINA
Device Problem Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/03/2023
Event Type  malfunction  
Event Description
It was reported while using bd smartsite¿ needle-free connector, priming volume 0.11 ml there was a blockage.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: when the transfusion was replaced, it was found that the fluid did not flow out.After careful observation, it was found that the infusion joint was blocked and completely closed, resulting in the liquid could not flow out.Therefore, the infusion joint was replaced again.
 
Manufacturer Narrative
H6: investigation summary: a 2000e china product was not available for investigation; however, the customer indicated the lot number of the complaint sample was 22015562.The feedback provided by the customer suggests a complete occlusion was detected during use of the smartsite device.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 22015562 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.Previous complaints for occlusions have been related to features on the surface of the male luer of the connecting products.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.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the smartsite component in the past 12 months.
 
Event Description
It was reported while using bd smartsite¿ needle-free connector, priming volume 0.11 ml there was a blockage.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: when the transfusion was replaced, it was found that the fluid did not flow out.After careful observation, it was found that the infusion joint was blocked and completely closed, resulting in the liquid could not flow out.Therefore, the infusion joint was replaced again.
 
Manufacturer Narrative
Investigation summary a 2000e china product was not available for investigation; however, the customer indicated the lot number of the complaint sample was 22015562.The feedback provided by the customer suggests a complete occlusion was detected during use of the smartsite device.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 22015562 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.Previous complaints for occlusions have been related to features on the surface of the male luer of the connecting products.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.
 
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Brand Name
BD SMARTSITE¿ NEEDLE-FREE CONNECTOR, PRIMING VOLUME 0.11 ML
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
phillip emmert
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key17066518
MDR Text Key317660373
Report Number9616066-2023-01093
Device Sequence Number1
Product Code FPA
UDI-Device Identifier20885403498227
UDI-Public(01)20885403498227
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/15/2023
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 Catalogue Number2000E CHINA
Device Lot Number22015562
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/11/2023
Initial Date FDA Received06/05/2023
Supplement Dates Manufacturer Received06/15/2023
Supplement Dates FDA Received06/29/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/10/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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