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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 VALVE; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SMARTSITE¿ NEEDLE-FREE VALVE; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2000E
Device Problems Complete Blockage (1094); Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/27/2022
Event Type  malfunction  
Event Description
It was reported that the bd smartsite¿ needle-free valve unable to prime and disconnect/re-connected multiple times.The following information was provided by the initial reporter: unable to prime/flush valve.Syringe disconnected/re-connected multiple times.
 
Manufacturer Narrative
The initial reporter also notified the fda on (b)(6) 2022.Medwatch report # (b)(4).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
Investigation summary a complaint of set being unable to prime and disconnecting from syringe was received from the customer.No product or photo was returned by the customer.The customer complaints of flow issues and connection issues could not be verified due to the product not being returned for failure investigation.A device history record review for model 2000e lot number 22055457 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.
 
Event Description
It was reported that the bd smartsite¿ needle-free valve unable to prime and disconnect/re-connected multiple times.The following information was provided by the initial reporter: unable to prime/flush valve.Syringe disconnected/re-connected multiple times.
 
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Brand Name
BD SMARTSITE¿ NEEDLE-FREE VALVE
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
8015296192
MDR Report Key16369488
MDR Text Key309596269
Report Number9616066-2023-00202
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203011938
UDI-Public(01)07613203011938
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K960280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2000E
Device Catalogue Number2000E
Device Lot Number22055457
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/24/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/04/2022
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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