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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 17 INCH EXT SET W/1.2MF & SMS INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 17 INCH EXT SET W/1.2MF & SMS INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 20128E-0006
Device Problem Free or Unrestricted Flow (2945)
Patient Problem No Information (3190)
Event Date 12/03/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Fda device problem code: 2945. Fda patient problem code: 3190.
 
Event Description
It was reported that air entered the 17 inch ext set w/1. 2mf & sms filter as it was not intact. The following information was provided by the initial reporter: "customer reports: we are using extension set with smartsite in our paediatric ward. We had an incident with this product; the filter is not intact meaning that air comes in the filter. ".
 
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Brand Name17 INCH EXT SET W/1.2MF & SMS
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 22244
MX 22244
Manufacturer (Section G)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana 22244
MX 22244
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11103458
MDR Text Key224798733
Report Number9616066-2020-20708
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number20128E-0006
Device Lot Number20035850
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2020
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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