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

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.

• Brand Name: TEXIUM CLOSED MALE LUER WITH FEMAILE CAP
• 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 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 Key: 11293390
• MDR Text Key: 238332392
• Report Number: 9616066-2021-50179
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403221705
• UDI-Public: 10885403221705
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053049
• Number of Events Reported: 1
• 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 Received: 02/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/14/2020
• Device Catalogue Number: 10012241-0500
• Device Lot Number: 17126211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other