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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. Y EXT W/VLV PORTS & 2 SLD CLP INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. Y EXT W/VLV PORTS & 2 SLD CLP INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 20019E
Device Problems Leak/Splash (1354); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: one photo was submitted for quality investigation. The customer complaint of component damage - leak, the failure reported could not be verified. The tubing does appear to be kinked at the location indicated in the picture, however, it cannot be determined if this kink can be massaged out due to the physical sample not being submitted. A device history record review for the model and lot number was performed. There were no quality notifications issued for the failure mode reported by the customer during the production build of this set. Due to no physical sample being received, an investigation could not be performed and a root cause could not be determined. 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 y ext w/vlv ports & 2 sld clp had kinked tubing and leaked. The following information was provided by the initial reporter: "plastic tubing was damaged prior to use, the tubing appears crimped or possibly melted and there was a hole in so when the rn placed on her iv site and tried to draw from it, blood came out the extension tubing instead of in to the lab tube. ".
 
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Brand NameY EXT W/VLV PORTS & 2 SLD CLP
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 Key12425945
MDR Text Key269906945
Report Number9616066-2021-51969
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061285
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 08/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20019E
Device Catalogue Number20019E
Device Lot Number21026324
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 Received08/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/16/2021
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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