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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAXZERO NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET
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MAXZERO NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number MZ1000
Device Problems Complete Blockage (1094); Restricted Flow rate (1248); Fluid/Blood Leak (1250)
Patient Problem Bacterial Infection (1735)
Event Date 07/27/2021
Event Type  Injury  
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 the maxzero needleless connector leaked and had issues with blockage/occlusion during the infusion and while administering medication.The leakage resulted in clabsi being found in the nicu department.No further information has been provided.The following information was provided by the initial reporter: "this autoclave has many issues reported of leakage, difficulty in administering of medications with regard the negative pressure, as well as will cause occlusions for the continuous infusions.Two causes are under investigations of being clabsi as result of leakage of this autoclave.Nicu was free from clabsi for 9 months.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-09-16.H6: investigation summary: one mz1000 sample from lot 19126129 was received in sealed packaging for investigation.The connecting product in use at the time of the customer's experience was not returned to assist the investigation, however the customer indicates that leakage was identified from the connection to a vygon picc line after approximately one hour of infusion.A visual inspection of the returned sample did not identify any product defects or manufacturing issues which could have caused or contributed to the customer's experience.Pressure testing of the component did not identify any leakage from the maxzero or from the connection with other components.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 19126129 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The customer¿s experience was not confirmed in this instance.Testing of the returned samples and a review of the production records did not identify any product defects or quality deviations during assembly.The alleged complaint sample was not available for investigation therefore it was not possible to confirm whether a manufacturing defect may have contributed to the reported leakage.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the maxzero device in the past 12 months.
 
Event Description
It was reported that the maxzero needleless connector leaked and had issues with blockage/occlusion during the infusion and while administering medication.The leakage resulted in clabsi being found in the nicu department.No further information has been provided.The following information was provided by the initial reporter: "this autoclave has many issues reported of leakage, difficulty in administering of medications with regard the negative pressure, as well as will cause occlusions for the continuous infusions.Two causes are under investigations of being clabsi as result of leakage of this autoclave.Nicu was free from clabsi for 9 months.".
 
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Brand Name
MAXZERO NEEDLELESS CONNECTOR
Type of Device
INTRAVASCULAR ADMINISTRATION SET
MDR Report Key12365071
MDR Text Key268051010
Report Number9616066-2021-51885
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 09/08/2021
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? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/18/2022
Device Catalogue NumberMZ1000
Device Lot Number19126129
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2021
Date Manufacturer Received09/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/10/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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