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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); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/27/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: na.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 maxzero needleless connector experienced a case of flow issues, a case of being clogged, and a case of leakage.The following information was provided by the initial reporter: connection between maxzero and luer lock equipment showing leakage in some cases.There was a change of 10ml syringes, before they used bd luer lock syringes, today with the 10ml luer slip syringe the b braun syringe infusion pumps signal occlusion and when they remove the maxzero solves the problem.Noted the occlusion after 15-20 minutes of use.Was there any harm to the patient/healthcare provider? (detail) -there was no harm to the professional or the patient.Was there any exposure to blood or chemotherapy to mucous membranes or skin? if so, was the exposure to the patient or the professional? was the professional using ppe? -there was no exposure of blood or chemotherapy to mucous membranes or skin.
 
Event Description
It was reported that maxzero needleless connector experienced a case of flow issues, a case of being clogged, and a case of leakage.The following information was provided by the initial reporter: connection between maxzero and luer lock equipment showing leakage in some cases.There was a change of 10ml syringes, before they used bd luer lock syringes, today with the 10ml luer slip syringe the b braun syringe infusion pumps signal occlusion and when they remove the maxzero solves the problem.Noted the occlusion after 15-20 minutes of use.Was there any harm to the patient/healthcare provider? (detail) -there was no harm to the professional or the patient.Was there any exposure to blood or chemotherapy to mucous membranes or skin? if so, was the exposure to the patient or the professional? was the professional using ppe? -there was no exposure of blood or chemotherapy to mucous membranes or skin.
 
Manufacturer Narrative
H6: investigation summary: an mz1000 product was not available for investigation; however the customer confirmed that the complaint sample was from lot 21015538.The customer provided a photograph of the affected sample; analysis of the photograph did not identify any obvious signs of damage or product defects which could have contributed to the customer's experience.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 21015538 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 this is a rare occurrence with a small number of similar reports against the mz1000 product in the past 12 months.H3 other text : see h10.
 
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Brand Name
MAXZERO NEEDLELESS CONNECTOR
Type of Device
INTRAVASCULAR ADMINISTRATION SET
MDR Report Key12520244
MDR Text Key272954518
Report Number9616066-2021-52119
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 09/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberMZ1000
Device Lot Number21015538
Was Device Available for Evaluation? No
Date Manufacturer Received09/28/2021
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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