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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 Leak/Splash (1354); Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/10/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that 3 maxzero needleless connectors leaked.The following information was provided by the initial reporter: "when we performed training on the maxzero connector, nurses and nursing technicians from the pediatric sector reported the break/crack in the connector so that the solutions leaked through the device".
 
Event Description
It was reported that 3 maxzero needleless connectors leaked.The following information was provided by the initial reporter: "when we performed training on the maxzero connector, nurses and nursing technicians from the pediatric sector reported the break/crack in the connector so that the solutions leaked through the device.".
 
Manufacturer Narrative
H6: investigation summary a mz1000 product was not available for investigation; however the customer confirmed that the complaint sample was from lot 21015541.As part of the investigation, the customer provided a photograph and video of the affected sample; analysis of the photograph and video identified leakage from the connection to the female luer adaptor (fla) of the component confirming the customer's experience.The details of this feedback were forwarded to the manufacturing site for investigation.They performed an in-depth investigation in order to determine a potential root cause for the customer's experience; during the investigation no obvious manufacturing defects or potential manufacturing contributors were identified which may have resulted in the observed leakage.A review of the production records for lot 21015541 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Although a definitive root cause could not be determined in this instance, previous investigations have confirmed similar leakage can occur from a crack to the female luer of the maxzero, which can be caused or contributed to by a combination of different factors, including prolonged use of substances that are aggressive to plastics, over-torque of the component during connection with the male luer, or use of a male luer that is not compliant to iso standards.In this instance based on the information available, it is not possible to determine which of these factors may have contributed to the customer's experience.A review of the customer feedback database indicates that complaints of this nature against the maxzero product occur at a low frequency and have not been attributable to a product defect or manufacturing issue.H3 other text : see h10.
 
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Brand Name
MAXZERO NEEDLELESS CONNECTOR
Type of Device
INTRAVASCULAR ADMINISTRATION SET
MDR Report Key12439314
MDR Text Key270319950
Report Number9616066-2021-51985
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 09/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberMZ1000
Device Lot Number21015541
Was Device Available for Evaluation? No
Date Manufacturer Received09/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/07/2021
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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