MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD SET XTN .4ML 9.5IN IV NDL FREE CONN SMALLBORE SPN M LL; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 20019E

Device Problem Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Date 02/12/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.B3.The date received by manufacturer has been used for this field.E1.Address information was not provided, therefore, xx was used as a place holder.

Event Description

It was reported that bd set xtn.4ml 9.5in iv ndl free conn smallbore spn m ll line occluded.The following information was provided by the initial reporter: nurse attempted to flush both needleless connector ports.One side flushed as it should.The other side was unable to be flushed, as if something was obstructing it.

• Brand Name: BD SET XTN .4ML 9.5IN IV NDL FREE CONN SMALLBORE SPN M LL
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18827873
• MDR Text Key: 337743270
• Report Number: 9616066-2024-00351
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 27613203013813
• UDI-Public: (01)27613203013813
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 20019E
• Device Lot Number: 23115175
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1