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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SEC 20DP, TEXIUM & HANGER V/NV INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SEC 20DP, TEXIUM & HANGER V/NV INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 40000-07T
Device Problems Separation Failure (2547); Separation Problem (4043)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/08/2021
Event Type  malfunction  
Event Description
It was reported 2 bd sec 20dp, texium & hanger v/nv experienced separation with no leakage the following information was provided by the initial reporter: separation other component- no leak, when tubing removed from package it was reported that the tubing came apart when removing tubing from packages.
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete. Upon completion, a supplemental report will be filed. Medical device expiration date: unknown. Device manufacture date: unknown.
 
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Brand NameSEC 20DP, TEXIUM & HANGER V/NV
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12980256
MDR Text Key285339847
Report Number9616066-2021-52575
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeCA
PMA/PMN Number
K790582
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/05/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number40000-07T
Device Catalogue Number40000-07T
Device Lot Number20095693
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/05/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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