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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAXPLUS POSITIVE PRESSURE CONNECTOR INTRAVASCULAR ADMINISTRATION SET

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MAXPLUS POSITIVE PRESSURE CONNECTOR INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number MP1000-C
Device Problems Complete Blockage (1094); Restricted Flow rate (1248)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/13/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone#: (b)(6). 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 nine maxplus positive pressure connector had flow issues and were clogged/blocked/occluded. The following information was provided by the initial reporter, translated from chinese: "for the same infusion set, fluid is drained from the first connector, but fluid is not drained from the second connector. ".
 
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Brand NameMAXPLUS POSITIVE PRESSURE CONNECTOR
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
MDR Report Key12467336
MDR Text Key271275382
Report Number9616066-2021-52033
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K072542
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 09/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMP1000-C
Device Catalogue NumberMP1000-C CHINA
Device Lot Number20015137
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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