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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MAXPLUS POSITIVE PRESSURE CONNECTOR INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MAXPLUS POSITIVE PRESSURE CONNECTOR INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number MP1000-C
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem Insufficient Information (4580)
Event Date 06/28/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. Device manufacture date: unknown. Investigation: a complaint of unidentifiable substance being found on the needless connector was received from the customer. No product or photo was returned by the customer. The customer complaint of foreign matter could not be verified due to the product not being returned for failure investigation. A device history record review could not be performed on model mp1000-c because a lot number was not provided by the customer. Due to no sample being received, an investigation could not be performed and a root cause could not be determined. 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 maxplus positive pressure connector had debris in the connector. The following information was provided by the initial reporter: "odd material showing up in needless connector unidentifiable material in cap that was not there upon initial use".
 
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Brand NameMAXPLUS POSITIVE PRESSURE CONNECTOR
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana
MDR Report Key12234938
MDR Text Key265791373
Report Number9616066-2021-51621
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 company representative,other
Type of Report Initial
Report Date 06/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/27/2021
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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