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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS INFUSION SET INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS INFUSION SET INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2420-0500
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/16/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: one sample was received for quality investigation. The customer complaint of component damage - leak was verified by visual inspection. Evaluation of the infusion set indicated that the tubing separated from the lower male luer connection. Examination of the sample under magnification indicates a lack of solvent on the end of the tubing and within the male luer connection. A device history record review for model 2420-0500, lot number 21063387 was performed. The search showed that a total of (b)(4) in 1 lot number was built on 26jun2021. There were no quality notifications issued for the failure mode reported by the customer during the production build of this set. The root cause for the issue seen in this complaint is a lack of solvent on the tubing and the male luer connection. Investigation of the union location shows a lack of solvent on both the tubing and male luer connection surfaces. This incident has been added to our database of reported incidents. Our business team regularly reviews the collected data for identification of emerging trends. The root cause for the issue seen in this complaint is a lack of solvent on the tubing and the male luer connection. Investigation of the union location shows a lack of solvent on both the tubing and male luer connection surfaces. A notification has been sent to the manufacturing facility to monitor the occurrence of this issue.
 
Event Description
It was reported that the bd alaris infusion set experienced device damage while still considered operable. The following information was provided by the initial reporter: i had a primed alaris infusion set at the bedside that was primed only 5 minutes prior to that. I brought the patient in and started an iv and checked the alaris infusion set tubing and it completely broke at the end when i was getting it ready to connect to the patient. It completely broke at the end where the tubing is connected to the end port. Saline came flushing out. I put this tubing aside to send back a product concern report. A new alaris infusion set was used for this patient.
 
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Brand NameBD ALARIS INFUSION 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 Key12827774
MDR Text Key284809109
Report Number9616066-2021-52434
Device Sequence Number1
Product Code FPA
UDI-Device Identifier37613203012448
UDI-Public37613203012448
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2420-0500
Device Catalogue Number2420-0500
Device Lot Number21063387
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/19/2021
Was Device Evaluated by Manufacturer? Yes
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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