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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MAXZERO¿ ZERO REFLUX IV CONNECTOR; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MAXZERO¿ ZERO REFLUX IV CONNECTOR; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number MZ1000-BR
Device Problems Crack (1135); Leak/Splash (1354); Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/26/2022
Event Type  malfunction  
Event Description
It was reported that three bd maxzero¿ zero reflux iv connector has cracks causing leakage and air in line.The following information was provided by the initial reporter: the plug cracks at the distal end, causing saline to leak and air to enter the blood samples.In addition, even though no breakage or crack is seen in the connector, air enters the connection.
 
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.Initial reporter address: (b)(6).
 
Manufacturer Narrative
H6: investigation summary: a mz1000-br product was not available for investigation; however the customer indicated the complaint sample was from lot 21056467.The feedback provided by the customer indicates although no visible damage was detected, air was present and observed to be entering the maxzero product.No further information was provided by the customer 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 21056467 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.H3 other text : see h10.
 
Event Description
It was reported that three bd maxzero¿ zero reflux iv connector has cracks causing leakage and air in line.The following information was provided by the initial reporter: the plug cracks at the distal end, causing saline to leak and air to enter the blood samples.In addition, even though no breakage or crack is seen in the connector, air enters the connection.
 
Manufacturer Narrative
Additional investigation information h.6.Investigation summary: a mz1000-br product was not available for investigation; however the customer indicated the complaint sample was from lot 21056467.The feedback provided by the customer indicates although no visible damage was detected, air was present and observed to be entering the maxzero product.No further information was provided by the customer 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 21056467 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.A review of the customer feedback database indicates that complaints of this nature are rare and there is currently no trend for issues of this nature against the maxzero product over the past 12 months.---------- a mz1000-br product was not available for investigation; however the customer indicated the complaint sample was from lot 21056467.The feedback provided by the customer indicates saline solution was leaking from a crack at the "distal" end of the maxzero product.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 21056467 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 complaint 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.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the maxzero product in the past 12 months.
 
Event Description
It was reported that three bd maxzero¿ zero reflux iv connector has cracks causing leakage and air in line.The following information was provided by the initial reporter: the plug cracks at the distal end, causing saline to leak and air to enter the blood samples.In addition, even though no breakage or crack is seen in the connector, air enters the connection.
 
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Brand Name
MAXZERO¿ ZERO REFLUX IV 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
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 Key14789534
MDR Text Key295335684
Report Number9616066-2022-00759
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeBR
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,Followup
Report Date 08/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberMZ1000-BR
Device Lot Number21056467
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/27/2021
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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