MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD AS LVP 20D LOW SORB SS 0.2M; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 10010454

Device Problem Material Separation (1562)

Patient Problem Chemical Exposure (2570)

Event Date 12/29/2023

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.

Event Description

It was reported that bd as lvp 20d low sorb ss 0.2m separated.The following information was provided by the initial reporter: folfiri infusing via pump.Patient found holding the bottom of the line which was previously connected to his portacath.Tubing came apart at the lowest part of the connection.Pump stopped.Irinotecan drops on patient's sweater, armchair, table and floor.Product: 2420-0007.

• Brand Name: BD AS LVP 20D LOW SORB SS 0.2M
• 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: 18952403
• MDR Text Key: 338365268
• Report Number: 9616066-2024-00454
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203015814
• UDI-Public: (01)37613203015814
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10010454
• Device Lot Number: 23105095
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1