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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. PRESSURE RATED EXT, REMOVABLE IV CONNEC INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. PRESSURE RATED EXT, REMOVABLE IV CONNEC INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number MZ5304
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/02/2021
Event Type  malfunction  
Manufacturer Narrative
Device expiration date: unknown. Device manufacture date: unknown. Investigation summary: a complaint of tubing rupturing and leaking during use was received from the customer. A photo was provided for investigation of this defect. Through visual inspection, the customer complaint was confirmed. The tubing and a long cut in it and was leaking. A device history record review could not be performed on model mz5304 because a lot number was not provided by the customer. A root cause could not be determined as a physical sample was not returned. This incident has been added to our database of reported incidents. Our business team regularly reviews the collected data for identification of emerging trends. Investigation conclusion: a photo was provided for investigation of this defect. Through visual inspection, the customer complaint was confirmed. The tubing and a long cut in it and was leaking. A root cause could not be determined as a physical sample was not returned.
 
Event Description
It was reported that the pressure rated ext, removable iv connec experienced device damage while still considered operable, and leakage. The following information was provided by the initial reporter: tubing ruptured.
 
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Brand NamePRESSURE RATED EXT, REMOVABLE IV CONNEC
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
Manufacturer (Section G)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12555697
MDR Text Key274081786
Report Number9616066-2021-52145
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140831
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMZ5304
Device Catalogue NumberMZ5304
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2021
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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