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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 NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MAXZERO NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number MZ1000
Device Problems Backflow (1064); Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/27/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that blood back-flowed through maxzero needleless connector when the syringe was removed, leaking from and clotting around the sides.The following information was provided by the initial reporter: "after the removal of syringe from the adapter, the blood is coming around the adapter sides.The patient are concerned about that, even though the blood is clotting around the sides.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 10/21/2021 h.6.Investigation: 2 samples were received for investigation.One sample was received in open packaging.The sample received in opened packaging had residual blood inside.One sample was received in sealed packaging.Further information provided by the customer indicates that blood backflow was observed from the patient and into the product connected to the maxzero.A visual inspection of the returned samples did not identify any product defects of manufacturing issues which could have caused or contributed to the customer's experience.Pressure testing did not identify any leakage from any of the returned samples.A review of the production records did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.In this instance, a definitive root cause could not be identified as testing of the returned samples did not identify any product defects that could have contributed to the customer¿s experience.
 
Event Description
It was reported that blood back-flowed through maxzero needleless connector when the syringe was removed, leaking from and clotting around the sides.The following information was provided by the initial reporter: "after the removal of syringe from the adapter, the blood is coming around the adapter sides.The patient are concerned about that, even though the blood is clotting around the sides.".
 
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Brand Name
MAXZERO NEEDLELESS 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12365079
MDR Text Key268051352
Report Number9616066-2021-51886
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeBA
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 10/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/05/2023
Device Catalogue NumberMZ1000
Device Lot Number20085530
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/03/2020
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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