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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 Problem Complete Blockage (1094)
Patient Problem Fever (1858)
Event Date 04/24/2021
Event Type  Injury  
Manufacturer Narrative
Investigation summary: an mz1000 product was not available for investigation; however the customer confirmed that the complaint sample was from lot 20085530. No further information was available to assist the investigation in this instance. The details of this feedback were forwarded to the manufacturing site for investigation. 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 production records for lot 20085530 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature. Please note as stated in the directions for use of the maxzero valve "flush the maxzero after each use with normal saline or in accordance with facility protocol. " "failure to properly prime the device can result in reflux. " a review of the customer feedback database indicates that reports of this nature against the maxzero product occur at a low frequency and have not been attributable to a product defect or manufacturing issue.
 
Event Description
It was reported that the maxzero needleless connector had flow issues that required to patient to receive three separate curatives in less than 72 hours. The following information was provided by the initial reporter, translated from spanish to english: patient with diagnosis of ileus transt. With epicutaneous catheter in msi ulnar fold. Catheter with positive pressure adapter (safeflow needle-free connector), catheter that repeatedly presented return despite having this device, also permeabilization of the catheter and 3 cures in less than 72 hours, finally they decided to withdraw the adapter and the catheter continues to function and does not return.
 
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Brand NameMAXZERO NEEDLELESS CONNECTOR
Type of DeviceINTRAVASCULAR 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 Key11957540
MDR Text Key254872609
Report Number9616066-2021-51272
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberMZ1000
Device Lot Number20085530
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/12/2021
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 Treatment Data
Date Received: 06/08/2021 Patient Sequence Number: 1
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