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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 ALARIS¿ SMARTSITE¿ NEEDLE-FREE CONNECTOR EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ SMARTSITE¿ NEEDLE-FREE CONNECTOR EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 20019E7D
Device Problems Backflow (1064); Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/13/2022
Event Type  malfunction  
Event Description
It was reported that the bd alaris¿ smartsite¿ needle-free connector extension set tubing was torn and leaked blood, which also backflowed into the pump.The following information was provided by the initial reporter: "the iv set was found torn and leaking.The iv set was also found to have blood back flow on a pump.".
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary a 20019e7d sample was not available for investigation; however, the customer indicated the complaint sample was from lot 21105413.The feedback provided by the customer indicates blood backflow issues were detected during infusion with the smartsite extension set.The customer also confirmed leakage was detected from a connecting iv set which had a hole in the tubing.As part of the investigation the customer provided a photograph of the packaging of the complaint sample however no further information was available to assist the investigation.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 21105413 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.
 
Event Description
It was reported that the bd alaris¿ smartsite¿ needle-free connector extension set tubing was torn and leaked blood, which also backflowed into the pump.The following information was provided by the initial reporter: "the iv set was found torn and leaking.The iv set was also found to have blood back flow on a pump".
 
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Brand Name
BD ALARIS¿ SMARTSITE¿ NEEDLE-FREE CONNECTOR EXTENSION SET
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 Key15561019
MDR Text Key303412733
Report Number9616066-2022-01501
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203014854
UDI-Public(01)07613203014854
Combination Product (y/n)N
Reporter Country CodeIN
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 10/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number20019E7D
Device Lot Number21105413
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/05/2021
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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