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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 7-DAY LL VLV ADPT(STAND ALONE) INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 7-DAY LL VLV ADPT(STAND ALONE) INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 2000E7D
Device Problem Leak/Splash (1354)
Patient Problem Exposure to Body Fluids (1745)
Event Date 12/01/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device lot #: the customer provided lot # 1016664. This does not match the catalog number provided. Medical device expiration date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown. (b)(4).
 
Event Description
It was reported that 7-day ll vlv adpt (stand alone) leaked. The following information was provided by the initial reporter: connector that leaks through the input port. Additional information received on 09. Dec. 2020 ((b)(6), 11. Dec. 2020): there was no patient injury. The event happened after device use. There was blood exposure.
 
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Brand Name7-DAY LL VLV ADPT(STAND ALONE)
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 22244
MX 22244
Manufacturer (Section G)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana 22244
MX 22244
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11092236
MDR Text Key231786448
Report Number9616066-2020-20679
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2000E7D
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 Received01/18/2021
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

Patient Treatment Data
Date Received: 12/29/2020 Patient Sequence Number: 1
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