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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. LL VLV ADPT(STAND ALONE); INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. LL VLV ADPT(STAND ALONE); INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 2000E CHINA
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/09/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the ll vlv adpt(stand alone) experienced foreign matter in fluid path.The following information was provided by the initial reporter: during surgical, foreign matter were found at the joint screw.There were photos and samples could be returned, and 1 was affected.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 8/24/2021.H.6.Investigation: one 2000e china sample from lot 21025825 was received in open packaging for investigation; no residual fluid was present in the sample.A visual inspection confirmed the customer's experience as a brown contaminant was identified to be embedded within the plastic on the inner side of the male luer.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the moulding process did not identify a definitive root cause for contamination of this nature; however it is likely that the contamination was caused by burnt material which may have occurred on startup of the moulding process.In such instances the initial components are typically segregated and disposed of, however in this instance it is likely that the affected component was not segregated and continued onto subsequent assembly processes due to human error.A review of the production records for lot 21025825 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The production personnel have been informed of this complaint in order to be aware of the reported failure mode during future production of this product.
 
Event Description
It was reported that the ll vlv adpt(stand alone) experienced foreign matter in fluid path.The following information was provided by the initial reporter: during surgical, foreign matter were found at the joint screw.There were photos and samples could be returned, and 1 was affected.
 
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Brand Name
LL VLV ADPT(STAND ALONE)
Type of Device
INTRAVASCULAR 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 Key12436292
MDR Text Key270216451
Report Number9616066-2021-51976
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K960280
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,Followup
Report Date 10/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/09/2024
Device Catalogue Number2000E CHINA
Device Lot Number21025825
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/08/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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