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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 8-IN PRESSURE RATED EXTENSION SET INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 8-IN PRESSURE RATED EXTENSION SET INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number MX5301
Device Problem Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/14/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation summary: one sample was received for quality investigation. The customer complaint of component damage could not be verified by investigation. The sample was first visually inspected for any physical defects or damage and nothing was observed. The connection between the male luer lock and the cannula that was submitted with the sample. The male luer connection was secure to the cannula and the connection was not loose. The extension set was then attached to a syringe and fluids were pushed through the tubing. There was no leakage at the luer connection, and there was no occlusion or air in line observed during the testing. A device history record review for model mx5301 lot number 21025131 was performed. The search showed that a total of 12,803 units in 1 lot number was built on (b)(6) 2021. There were no quality notifications issued for the failure mode reported by the customer during the production build of this set. Investigation conclusion: this incident has been added to our database of reported incidents. Our business team regularly reviews the collected data for identification of emerging trends. Root cause description: a root cause could not be determined due to the issue reported not being able to be replicated.
 
Event Description
It was reported that 8-in pressure rated extension set was difficult to disconnect. The following information was provided by the initial reporter: it was reported by the customer that the spin on the male leur lock does not secure. Verbatim: the spin on the male leur lock does not seem to secure. When it does secure, the male leur is almost jammed in to the iv catheter hub and at times cannot be removed by hand.
 
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Brand Name8-IN PRESSURE RATED EXTENSION SET
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 Key12162957
MDR Text Key261482757
Report Number9616066-2021-51506
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051499
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 06/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberMX5301
Device Lot Number21025131
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/28/2021
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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