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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 7" (18 CM) PRESSURE RATED EXT SET W/REMO INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 7" (18 CM) PRESSURE RATED EXT SET W/REMO INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number MP5314-C
Device Problems Separation Failure (2547); Separation Problem (4043)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: no product or photo was returned by the customer. The customer complaint of issues with the connector popping out of the extension set and foam like substance in the tip 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 mp5314-c because a valid lot number was not provided by the customer. The root cause of this failure could not be identified without a failure investigation. 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 connector separated from the 7" (18 cm) pressure rated ext set w/remo during use. The following information was provided by the initial reporter: "the chemo nurses in our medical oncology department are reporting some issues with the connector popping out of the mp5314-c extension set. They stated that there is a foam-like substance in the tip that they believe is causing it to pop out. ".
 
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Brand Name7" (18 CM) PRESSURE RATED EXT SET W/REMO
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 Key12264638
MDR Text Key264716142
Report Number9616066-2021-51687
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083472
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 07/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMP5314-C
Device Catalogue NumberMP5314-C
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 Received07/06/2021
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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