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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. Y EXT W/VLV PORTS & 2 SLD CLP INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. Y EXT W/VLV PORTS & 2 SLD CLP INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 20019E
Device Problem Leak/Splash (1354)
Patient Problem Not Applicable (3189)
Event Date 09/15/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that y ext w/vlv ports & 2 sld clp had a loose connection on 2 occasions. The following information was provided by the initial reporter: event 2 originated from bag 10: customer sent one used 20019e, lot number: 20045838. Attached to one used 3ml bd syringe, lot number: 0127937, exp: 2023-04-30. Customer sent one used 20019e, lot number: 20045838; curos cap attached to smartsite. Attached to one used 20038e, lot number: unknown. The customer attached a sticky note stating, "both of these bifurcats just "spinned" when i (didn't lock/tighten) tried to connect my ivf to my piv-had to use a trifurcate. ".
 
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Brand NameY EXT W/VLV PORTS & 2 SLD CLP
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
8015652341
MDR Report Key10646162
MDR Text Key210658936
Report Number9616066-2020-20032
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061285
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,Followup
Report Date 11/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number20019E
Device Catalogue Number20019E
Device Lot Number20045838
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/05/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/08/2020
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: 10/07/2020 Patient Sequence Number: 1
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