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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. TEXIUM CLOSED MALE LUER WITH FEMAILE CAP INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. TEXIUM CLOSED MALE LUER WITH FEMAILE CAP INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 10012241-0500
Device Problem Leak/Splash (1354)
Patient Problem Underdose (2542)
Event Date 09/30/2020
Event Type  Injury  
Manufacturer Narrative
Mfr report #: the original mfr report # was 2016493-2020-80002 was submitted with the incorrect mfr registration site number. Although the original mdr referenced the incorrect mfr site the mdr was submitted 21 october 2020 and was on time. (b)(4). Investigation: the customer sent in a texium connector attached to a halyard homeseries c-pump with the complaint of leakage at the texium site. After testing, the leakage could not be duplicated and is likely due to an incompatible connection with bd device. Though texium meets iso specifications, it is advised that the product be used with smartsite bd products. A device history record review for model 10012241-0500, lot number 17126211 was performed. There were no quality notifications issued for the failure mode reported by the customer during the production build of this set. A root cause was not determined as the complaint of leakage could not be replicated.
 
Event Description
It was reported that 6 texium closed male luer with female cap leaked during use. The following was reported by the initial reporter: "it was reported that there is a leaking issue when using the texium closed male luer with the c-series pump iv line. Describe customer concern: this event has occured 7 times in the last two days and several times earlier this week-last pir submitted. The issue is with our texium, ct # 10012241-0500. Our texium (female end) is being connected to the customer's halyard c-series elastomeric pump. Fixed male swivel luer lock end of the iv line. 5fu is being administered and has leaked between the connections. Our texium is being used with all types of homecare sets and applications, ie: buddy pump set but this issue of leaking is only occurring with the c-series pump-iv line.
 
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Brand NameTEXIUM CLOSED MALE LUER WITH FEMAILE CAP
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 Key11293390
MDR Text Key238332392
Report Number9616066-2021-50179
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053049
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 02/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/14/2020
Device Catalogue Number10012241-0500
Device Lot Number17126211
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/07/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/14/2017
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: 02/08/2021 Patient Sequence Number: 1
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