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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 W/SS DC 20DP & HANGER TEX INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SEC W/SS DC 20DP & HANGER TEX INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 10013364T
Device Problem Leak/Splash (1354)
Patient Problem No Information (3190)
Event Date 12/02/2020
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. (b)(4).
 
Event Description
It was reported that the sec w/ss dc 20dp & hanger tex experienced component separation and leakage. The following information was provided by the initial reporter: material #: (b)(4), batch/ lot #: 20095609, we report that we are have issues with this chemo tubing. In the past 2 weeks, 3 of these sets have snapped in half and had chemo spilling out. I think it¿s obviously an issue with a lot.
 
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Brand NameSEC W/SS DC 20DP & HANGER TEX
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 Key11122061
MDR Text Key226653661
Report Number9616066-2021-00003
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K790582
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,Followup
Report Date 01/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number10013364T
Device Lot Number20095609
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 Received01/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2020
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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