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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 36 IN 15 DROP SECONDARY SET W/HGR INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 36 IN 15 DROP SECONDARY SET W/HGR INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number MS3500-15
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/06/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used as a default. Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: one sample was received for quality investigation. The customer complaint of foreign matter was verified by visual inspection. Evaluation of the sample received reveals a brown colored foreign matter on the spike of the drip chamber. A device history record review could not be performed on model ms3500-15 because a lot number was not provided by the customer. The root cause for the issue seen in this complaint is an issue that has been previously investigated from similar reported failure modes. The brown foreign matter is grease that is used during the molding process of the drip chamber spike. The grease was not fully removed after the molding process during the assembly and manufacturing of the infusion set. 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 that 36 in 15 drop secondary set w/hgr contained foriegn matter on the spike. The following information was provided by the initial reporter: "it was reported that the spike was dirty in closed packaging. ".
 
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Brand Name36 IN 15 DROP SECONDARY SET W/HGR
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 Key12426042
MDR Text Key269906843
Report Number9616066-2021-51974
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
Report Date 08/13/2021
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 Other
Device Model NumberMS3500-15
Device Catalogue NumberMS3500-15
Device Lot NumberUNKNOWN
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
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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