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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SMALLBORE 6 INCH EXT VLV INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SMALLBORE 6 INCH EXT VLV INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 20039E
Device Problems Complete Blockage (1094); Restricted Flow rate (1248); Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/30/2021
Event Type  malfunction  
Manufacturer Narrative
No product or photo was returned by the customer. The customer complaint of tubing kinked could not be verified due to the product not being returned for failure investigation. A device history record review for model 20039e lot number 20125924 was performed. The search showed that a total of 24,003 units in 1 lot number was built on 10dec2020. There were no quality notifications issued for the failure mode reported by the customer during the production build of this set. A device history record review for model 20039e lot number 20125584 was performed. The search showed that a total of 24,003 units in 1 lot number was built on 04dec2020. There were no quality notifications issued for the failure mode reported by the customer during the production build of this set. Due to no sample being received, an investigation could not be performed and a root cause could not be determined. ".
 
Event Description
It was reported that a smallbore 6 inch ext vlv was clogged and had tubing kink during use. The following was reported by the initial reporter: "clinician opens the iv start kit. Then they open the bd iv extension set, tubing, 6". The tubing has a "crimp" and will clog or block the iv solution from going through the tubing set. ".
 
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Brand NameSMALLBORE 6 INCH EXT VLV
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 Key11925069
MDR Text Key263496759
Report Number9616066-2021-51236
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K960280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number20039E
Device Catalogue Number20039E
Device Lot Number20125924
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2020
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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