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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 Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2021
Event Type  malfunction  
Manufacturer Narrative
Device expiration date: unknown. Device manufacture date: unknown. Investigation summary: a complaint of a blue cap cracking and leaking on a set was received from the customer. A used sample was received for investigation of this defect. Through visual inspection, no damages or defect were found on the sample. The sample was then primed and attached to a primary set for infusion. The infusion was completed with no issues. The customer complaint could not be replicated. A device history record review could not be performed on model mp1000-c because a lot number was not provided by the customer. A root cause could not be determined as the failure could not be replicated. This incident has been added to our database of reported incidents. Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that the maxplus positive pressure connector experienced device damage while still considered operable. The following information was provided by the initial reporter: bd maxzero needleless connector connected to patients broviac, and noticed blue cap cracked and leaking iv fluid. Immediately disconnected from patient and replaced with new cap. Had an issue with the max plus connector. The lot number was not recorded.
 
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Brand NameMAXPLUS POSITIVE PRESSURE CONNECTOR
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
MDR Report Key12425175
MDR Text Key269906929
Report Number9616066-2021-51958
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 other,user facility
Type of Report Initial
Report Date 08/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/03/2021
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
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/05/2021
Was Device Evaluated by Manufacturer? Yes
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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